29 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNMESH System
FDA 510(k)
FDA Class 2
·Orthopedic
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304270640·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515068292·Weitlaner Ret, shrp prng, 3x4, 6 1/2"
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515027275·Weitlaner Ret, shrp prng, 3x4, 6 1/2"
PERIOPATCH
FDA 510(k)
FDA Unclassified
·Unknown
EQUIVITAL
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMET ILOK PRI TIB TRAY 75MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 2, 2023
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2014
MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD
FDA Adverse Event
Malfunction
·MICROTYPING SYSTEMS·Product code KSZ·June 21, 2013
ENDOPATH** ETS45 ENDOSCOPIC LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 28, 2011
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
UNK- 18X 71/75 BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 6, 2023
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
VANGUARD(TM) CR FEMORAL 75MM RIGHT POROUS COATED/BOND COATED
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·January 7, 2017
REGENEREX BIOMET PRIMARY TIBIAL TRAY WITH LOCKING BAR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBH·August 16, 2017
REGENEREX POROUS TITANIUM PATELLA 3 PEG
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBH·August 16, 2017
MAXIM BIOMET KNEE SYSTEM MODULAR FINNED STEM WITH SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·August 16, 2017
VANGUARD KNEE SYSTEM LIPPED TIBIAL BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·August 16, 2017
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
VANGUARD (TM) DCM TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·November 1, 2019