AC-Powered Obstetrical Table and Accessories,Acoustic Fetal Stimulator Suppliers & Manufacturers

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AC-Powered Obstetrical Table and Accessories (FDA Code: HDD / 884.49)

Identification. An obstetric table is a device with adjustable sections designed to support a patient in the various positions required during obstetric and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support attachments, and cabinets for warming instruments and disposing of wastes.

Classification. Class II (performance standards).

Midmark Corporation, Enochs Examining Room Furniture, Stryker Trauma Gmbh

Acoustic Fetal Stimulator (FDA Code: MCP)
Applicare Medical Imaging, B.V.

Acoustical Fetal Holograph (FDA Code: HHX / 884.2225)

Identification. An obstetric-gynecologic ultrasonic imager is a device designed to transmit and receive ultrasonic energy into and from a female patient by pulsed echoscopy. This device is used to provide a visual representation of some physiological or artificial structure, or of a fetus, for diagnostic purposes during a limited period of time. This generic type of device may include the following: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, coupling gel, and component parts. This generic type of device does not include devices used to monitor the changes in some physiological condition over long periods of time.

Classification. Class II (performance standards).

Combined Instruments (Pvt.), Ltd.

Amniotic Fluid Sampler (FDA Code: HIO / 884.155)

Identification. The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amniotic sac via a transabdominal approach. Components of the amniocentesis tray include a disposable 3 inch 20 gauge needle with stylet and a 30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 884.9.

Vyaire Medical, Inc., Cook Group Incorporated, Cook Urological, more...

Amniotic Membrane Perforator
Howard Medical Company, Hollister Incorporated, Precision Dynamics Corporation, more...

Amniotic Trocar
Codman & Shurtleff, Inc., Karl Storz GmbH & Co. KG.

Amniotome (FDA Code: HGE / 884.453)

Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

Classification. (1) Class II (performance standards).

Cooper Surgical, Inc., Hollister Incorporated, Vyaire Medical, Inc., more...

Anomaly Detection by Ultrasonography
Foetal Medicine Consultancy Services

Assisted Reproduction Accessory (FDA Code: MQG / 884.612)

Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:

Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing).

Cook Group Incorporated, Cook Urological, Nuaire, Inc., more...

Assisted Reproduction Catheter (FDA Code: MQF / 884.611)

Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.

Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Cooper Surgical, Inc., Cook Group Incorporated, Cook Urological, more...

Assisted Reproduction Devices
Cooper Surgical, Inc., TKB International, Vitrolife, Inc., more...

Assisted Reproduction Labware (FDA Code: MQK / 884.616)

Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.

Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing).

Remel, Becton, Dickson & Co.,, GenX International, more...

Assisted Reproduction Laser System (FDA Code: MRX / 884.62)
Hamilton Thorne Biosciences, Research Instruments Ltd., MTG Medical Technology Vertriebs-Gmbh, more...

Assisted Reproduction Micromanipulators and Microinjectors (FDA Code: MQJ / 884.615)

Identification. Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assisted reproduction microtool.

Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing).

Narishige International Usa, Inc., Research Instruments Ltd., Narishige Co., Ltd.

Assisted Reproduction Microscope And Microscope Accessories (FDA Code: MTX / 884.619)

Identification. Assisted reproduction microscopes and microscope accessories (excluding microscope stage warmers, which are classified under assisted reproduction accessories) are optical instruments used to enlarge images of gametes or embryos. Variations of microscopes and accessories used for these purposes would include phase contrast microscopes, dissecting microscopes and inverted stage microscopes.

Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 884.9.

Appasamy Associates

Assisted Reproduction Microtools (FDA Code: MQH / 884.613)

Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.

Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing).

Conception Technologies, Cooper Surgical, Inc., Cook Group Incorporated, more...

Assisted Reproduction Needle (FDA Code: MQE / 884.61)

Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.

Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Cooper Surgical, Inc., Cook Group Incorporated, Cook Urological, more...

Assisted Reproduction Water Purification System (FDA Code: MTW / 884.617)

Identification. Assisted reproduction water purification systems are devices specifically intended to generate high quality, sterile, pyrogen-free water for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction procedures. These devices may also be intended as the final rinse for labware or other assisted reproduction devices that will contact the gametes or embryos. These devices also include bottled water ready for reconstitution available from a vendor that is specifically intended for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos for IVF or other assisted reproduction procedures.

Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, water quality testing, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Conception Technologies, Cooper Surgical, Inc., Whitehall Mfg Co

Baby Food Warmer
Philips Avent, Creche Innovations

Battery Breast Pump
Philips Avent

Biggs Mammary Retractors
Scanlan International, Accurate Surgical & Scientific Instruments Corporation

Biopsy Instruments (FDA Code: KNW / 876.1075)

Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification. (1) Class II (performance standards).

Angiotech Pharmaceuticals, Inc., Advanced Bionics Corporation, Autosuture, more...

Biopsy Punch Forceps
Elmed Inc., Codman & Shurtleff, Inc., U.S.E Surgical Instruments, more...

Bipolar Endoscopic Coagulator-Cutter and Accessories (FDA Code: HIN / 884.415)

Identification. A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables.

Classification. Class II. The special controls for this device are:

Elmed Inc., Kirwan Surgical Products, Gyrus ACMI, more...

Bipolar Forceps Scissors Handle
Millennium Surgical Corp., Cushy Surgical Co.

Bipolar Forceps Syringehandle
Millennium Surgical Corp., Cushy Surgical Co.

Bipolar Laparoscopic Equipment
Valleylab, Advin Health Care, Cushy Surgical Co.

Birthing Chair
Dabi Atlante

Breast Binder (FDA Code: HEF / 880.516)

Identification. A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Hospital Marketing Services Co., Inc., Vyaire Medical, Inc., Lenjoy Medical Engineering, Inc., more...

Breast Cancer Detection Kit Test
Polymedco Inc., Neomatrix, Medical Tactile, Inc., more...

Breast Lesion Documentation System (FDA Code: NKA / 884.299)

Identification. A breast lesion documentation system is a device for use in producing a surface map of the breast as an aid to document palpable breast lesions identified during a clinical breast examination.

Classification. Class II (special controls). The special control is FDA's guidance entitled "Class II Special Controls Guidance Document: Breast Lesion Documentation System." See 884.1(e) for the availability of this guidance document.

Medical Tactile, Inc., U-Systems, Inc.

Breast Pumps
A breast pump is a hand-operated or motor-driven device that creates suction. It collects mothers' milk into a baby bottle with a gentle rhythmical action. Most pumps contain a small motor that creates the suction, a breast shield, and a tube or channel to flow the milk into a collection bottle. Mechanically, a breast pump is directly analogous to a milking machine used in commercial dairy production. It may also be used to stimulate lactation for women with a low milk supply, or who have just given birth.
Herself Moms, Philips Avent, Howard Medical Company, more...

Breast Shell Set
Breast shell set is worn inside the bra to protect nipples from chafing and to collect leaking breast milk. It protects sore or cracked nipples to help them heal more quickly. Its gentle pressure helps relieve engorgement. The holes allow air to circulate.
Philips Avent, General Home Medical Supply Inc., Jintong (guangzhou) Medical & Healthcare Products Co., Ltd., more...

Breast Shields
Medela, Inc, Alimed, Inc., Kemper Medical, Inc., more...

Breast Ultrasonic Scanner
Siemens Medical Solutions USA Inc, Imaging Diagnostic Systems, Inc., Pie Medical Imaging B.V., more...

Cannulas
Salter Labs, SBH Surgical, Cramer Decker Medical,Inc., more...

Cardiac Fetal Monitor (FDA Code: KXN / 884.26)

Identification. A fetal cardiac monitor is a device used to ascertain fetal heart activity during pregnancy and labor. The device is designed to separate fetal heart signals from maternal heart signals by analyzing electrocardiographic signals (electrical potentials generated during contraction and relaxation of heart muscle) obtained from the maternal abdomen with external electrodes. This generic type of device may include an alarm that signals when the heart rate crosses a preset threshold. This generic type of device includes the "fetal cardiotachometer (with sensors)" and the "fetal electrocardiographic monitor."

Classification. Class II (performance standards).

CP Health Inc., Applied Medical, Sinnor Instruments, Inc.

Catheters
Catheter is a thin and flexible tube that can be inserted into a body cavity, duct or vessel in order to allow fluids to pass into or out of it, to distend (expand) it, or to convey diagnostic or other instruments through it. The process of inserting a catheter is catheterisation.
Alsius Corporation, Osmetech, Inc., Mentor Corporation, more...

Cerclage Suture Prosthesis (FDA Code: HHY)
Ethicon, Inc.

Cervical Biopsy Punch
B&H Surgical, Accolade Surgical Products, Elmed Inc., more...

Cervical Cone Knife (FDA Code: HDZ / 884.453)

Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

Classification. (1) Class II (performance standards).

Vyaire Medical, Inc., Teleflex Medical, Sigma Products Ltd., more...

Cervical Dilator
TKB International, Berkeley Medevices, Inc., Medgyn Products Inc, more...

Cervical Drain (FDA Code: HFL / 884.32)

Identification. A cervical drain is a device designed to provide an exit channel for draining discharge from the cervix after pelvic surgery.

Classification. Class II (performance standards).

Lalita Surgical Pvt. Ltd., Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

Cervical Mucus Viscometer (FDA Code: LHZ / 884.104)

Identification. A viscometer for cervical mucus is a device that is intended to measure the relative viscoelasticity of cervical mucus collected from a female patient. Measurements of relative viscoelasticity are intended for use as an adjunct in the clinical evaluation of a female with chronic infertility, to determine the time of ovulation and the penetrability of cervical mucus to motile sperm.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 884.9.

Boston Rheology, LLC, Biosense Corporation

Cervical Smear Kit
Monogen, Canadian Medical Brush, Inc.

Cervical Tenaculums
Medgyn Products Inc

Cesarean Section Kit (FDA Code: OHM / 884.172)

Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Classification. (1) Class II (performance standards).

Medline Industries, Inc., Roi, Consolidated Service Center (CSC)

Chemical Heat Pack (FDA Code: MPO / 890.571)

Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 890.9.

Autosuture, Cooper Surgical, Inc., Vyaire Medical, Inc., more...

Chemiluminescent Light Source (FDA Code: MPU / 884.453)

Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

Classification. (1) Class II (performance standards).

Zila Technical, Inc., Zila Therapeutics, Inc, Watson Diagnostics, Inc., more...

Chorionic Villus Sampling Catheter (FDA Code: LLX)
Cook Urological

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