14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Elecsys CMV IgG
FDA 510(k)
FDA Class 2
·Microbiology
Zavation
FDA UDI
Zavation LLC·00842166133112·Ti3Z CIF 14mmx16mmx11mm -9 deg
ZAVATION
FDA UDI
Zavation LLC·00842166105201·CIF 14x16, 9 deg, -11
ZEUS-P
FDA UDI
SPINAL ELEMENTS·00840916122980·Zeus-P Implant 11 x 9 x 22mm
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167312209110·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167322209110·
ZEUS-P
FDA UDI
SPINAL ELEMENTS·00840916153496·Zeus PLIF, Curved Cage 22mm x 09mm x 11mm
Inspire Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C33422091101·Porous PEEK PLIF Spacer, 22 x 9 x 11mm, 0 deg
MID LABS AUTONOMOUS VIT ENHANCER (AVE)
FDA 510(k)
FDA Class 2
·Ophthalmic
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
FDA 510(k)
FDA Class 2
·Microbiology
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE-SINGAPORE·Product code FRN·August 23, 2011
AMS
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code LNK·November 4, 2008
T5 LT WT FIBER OPT SURG HELMET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code FXZ·July 11, 2013
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 1, 2018