12 results
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17ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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HGR INSTRUMENTE GMBH
FDA registration
HGR INSTRUMENTE GMBH·119 products·🇩🇪 Germany
Fia Biomed GmbH
Importer
🇩🇪 Germany·1 Manufacturer
MED-RAS GmbH Regulatory Affairs Service
Authorized representative
🇩🇪 Germany·18 Manufacturers·235 Devices
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·December 17, 2025
Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
FDA Enforcement
Class III
·Terminated·Dannoritzer Medizintechnik GmbH & Co. KG·October 10, 2018
12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.
FDA Enforcement
Class II
·Terminated·Fetzer Medical GmbH & Co. KG·January 30, 2019
16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.
FDA Enforcement
Class II
·Terminated·Fetzer Medical GmbH & Co. KG·January 30, 2019
16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.
FDA Enforcement
Class II
·Terminated·Fetzer Medical GmbH & Co. KG·January 30, 2019
12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.
FDA Enforcement
Class II
·Terminated·Fetzer Medical GmbH & Co. KG·January 30, 2019
Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·October 11, 2017
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
FDA Enforcement
Class II
·Ongoing·Btt Health Gmbh·September 25, 2024
HGV - Verbandstoffe Gesellschaft mit beschränkter Haftung
System producer
🇩🇪 Germany