20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Spinal Elements Cerclage System
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001919·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001902·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001988·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001933·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001926·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001964·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001940·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001971·MCK Inlay Tibial Component
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486001957·MCK Inlay Tibial Component
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197086066·DESCHAMPS Ligature needle
21.0cm...
ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
LDR SPINE ROI-C IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·June 14, 2023
AUTOLUBE-III
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEY·October 17, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 20, 2013
MULTI DIAGNOST 4
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code JAA·May 5, 2011
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022
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