27 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VOLUMETRIC INCENTIVE SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052015947·Aggressive Full Radius Resector 5,5
Regenerex
FDA UDI
Biomet Orthopedics, LLC·00880304554405·
Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 17, 2017
OsteoMed
FDA UDI
OSTEOMED LLC·00845694046565·PrimaLIF LLIF PEEK Implant, 13mm X 26mm X 55mm,...
RGX 3 PEG SER A PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 3, 2019
AUGEASE VASCULAR AUGMENTATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
HUMERAL STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN VANGUARD TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 3, 2017
OLECRANON PLATE VARIAX FOR RIGHT ULNA 6 HOLE / L113MM
FDA Adverse Event
Injury
·STRYKER TRAUMA SELZACH·Product code HRS·June 3, 2013
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 1, 2011
SEPARATOR SYSTEM UNIV SEAL 15MM X 150MM
FDA Adverse Event
Other
·APPLIED MEDICAL RESOURCES·Product code GCJ·August 28, 2008
BIOMET TIBIAL LOCKING BAR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 6, 2020
BMT 360 7.5MM OFFSET ADAPTER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·January 22, 2020
VANGUARD PS OPEN BOX FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 25, 2019
VANGUARD PS TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 25, 2019
BIOMET FINNED PRI STEM 40MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 6, 2020
E1 VNGD PS TIB BRG 63/67X16 X 16
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 6, 2020
BMET REGENX PRI TIB TRAY 63MM COCR 63MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·August 6, 2020
CUS TI POR 59 360 TIB TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 2, 2019