13 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Empower RF Catheter
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OSE
FDA UDI
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC·00810042120020·.010 Short Twisted Preformed Stainless Steel Li...
SONTEC SLIM THERMOPLASTIC INSTRUMENT TRAY
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896019423·SONTEC SLIM THERMOPLASTIC INSTRUMENT TRAY
THERMOPLASTIC INSTRUMENT TRAY
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896099159·THERMOPLASTIC INSTRUMENT TRAY WITH MAT & LID WI...
3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W
FDA 510(k)
FDA Class 2
·Radiology
OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
VANGUARD CR ILOK FEM-LT 65
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018
BIOMET CC I-BEAM TRAY 67MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018
UNKNOWN PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018
11 CM ANGLE ATTACHMENT QD11
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 17, 2014
TECNIS 1-PIECE
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·June 21, 2013
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·July 28, 2011
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
FDA Enforcement
Class III
·Terminated·Biomet, Inc.·June 17, 2015