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Data / Medical devices / Forceps, Obstetrical

Forceps, Obstetrical (HDA): 36 FDA-registered makers in 7 countries

36 establishments in 7 countries are registered with the FDA to make Forceps, Obstetrical (product code HDA, Class 2, 21 CFR 884.4400). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on April 29, 2010, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
HDA
Device class
2
Regulation
884.4400
Medical specialty
Obstetrics/Gynecology

Makers by country

CountryMakers
United States13
Pakistan10
Germany9
China1
Australia1
Mexico1
Hungary1

Makers of Forceps, Obstetrical

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer1April 29, 2010000api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer1April 29, 2010000api.fda.gov
CovidienNorth Haven, CT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer1October 11, 1990000api.fda.gov
CovidienPonce, PR, United StatesContract manufacturer, Manufacturer1October 11, 1990000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer1January 8, 2010000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler1April 29, 2010000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1April 29, 2010000api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer1October 11, 1990000api.fda.gov
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Addn Solutions GMBH & Co. KGWurmlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
August Reuchlen GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
B.Braun Medical (Suzhou) Co,.LtdSuzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
CM Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Daud Jee MFG CoSialkot Punjab, PakistanManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Geomed Medizin-Technik GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Heinrich Medizintechnik GMBHStuttgart Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hexamed Pvt LtdSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
Meister Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Nypro Inc (Maple Grove)Maple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Princeton Medical Group, Inc.Franklin, TN, United StatesSpecification developer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Sitec (pvt.) Ltd.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesSpecification developer0000api.fda.gov
SUBAN Instruments Hungary Co.DEBRECEN Hajdu-Bihar, HungaryContract manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Vehu Medical Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Volgo Care International (private) LimitedSialkot Punjab, PakistanContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov

Updated April 29, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.