32 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMET KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304007628·
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868247996·
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868558702·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587T1412360·14mm TLIF Implant 12mm Wide 36mm Length
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515017825·Petit Point Mosquito Fcps, straight, 6"
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587T14123670·14mm TLIF Implant 12mm Wide 36mm Length 7 Degrees
VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM
FDA 510(k)
FDA Class 2
·Radiology
PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052
FDA 510(k)
FDA Class 2
·Dental
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606151559·14 X 12 CERVICAL TRIALS 36MM 0° LORDOSIS
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606151740·14 X 12 CERVICAL TRIALS 36MM 10° LORDOSIS
VANGUARD SERIES A PAT THIN 37X8.6 3 PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 3, 2026
BIOMET TIBIAL LOCKING BAR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 3, 2026
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013
PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 27, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 3, 2014
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·November 14, 2025
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·November 12, 2025
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 25, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 25, 2019