30 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BORRELIA BURGDORFERI IGM BLOT TEST
FDA 510(k)
FDA Class 2
·Microbiology
SCREW SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304213975·
5570 3L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136021942·5570 3L SYR SIBEL INTEGRAL ADP
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642105353·PS2 Screw 8.5mm x 45mm
ULTRAGARD IMPERVIOUS REINFORCED GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 10, 2021
MAESTRO TOTAL WRIST CAPITATE STEM 6X12MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWJ·August 7, 2018
INTEGRAL/XLAT POR PROFILE 13MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 22, 2018
MAESTRO TOTAL WRIST CARPAL HEAD 7X15MM STD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWJ·August 7, 2018
MAESTRO TOTAL WRIST RADIAL STEM 6.0X40MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWJ·August 7, 2018
MAESTRO TOTAL WRIST DISTAL RADIAL BODY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWJ·August 7, 2018
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR LLC·Product code OBR·May 1, 2014
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 15, 2013
VASOVIEW HEMOPRO 2 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·May 17, 2011
MAESTRO TOTAL WRIST CARPAL PLATE 9X37 AUG 6
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWJ·August 7, 2018
BI-METRIC CDH POR N/C 7X114
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·February 28, 2019
M2A 38MMX56MM CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·February 28, 2019
M2A 38MM MOD HD -6MM NK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·February 28, 2019
R3 XLPE INSERT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDI·May 25, 2025