27 results · 31ms · Sources: EU EUDAMED, 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