16 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NX01 (NX01)
FDA 510(k)
FDA Class 2
·Neurology
ELMED
FDA UDI
ELMED INCORPORATED·00842180165229·5 MM DIA., 45 CM, RETRACTOR / ELEVATOR WITH CUR...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776209216·KITE SHAPE RETElevator CVD ROT Lock
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668101261·SWISS MODEL BLADE BREAKER
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251550400·ceraMotion® Ti Bonder Powder, 40 g / dental cer...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197172196·Adventitia Scissors
straig...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197172226·Adventitia Scissors
straig...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197172202·Adventitia Scissors
straig...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197172219·Adventitia Scissors
straig...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251550200·ceraMotion® Ti Bonder Powder, 20 g / dental cer...
INSPIRATION VENTILATOR SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Evidence MultiSTAT DOA Urine MultiPlex
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY AG·Product code MTA·November 14, 2014
FEMORAL COMPONENT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC·Product code JDH·September 16, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 29, 2013
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019