23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES
FDA 510(k)
FDA Class 1
·Radiology
SMALL BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919094272·KM33-410
Brasseler USA
FDA UDI
Provision·00810041064950·
Reprocessed Small Bone Oscillating Saw Blade, 11.5 x 5.5 x 0.56mm
FDA UDI
SURETEK MEDICAL·B390KM334101·
SeaSpine Spacer System - Pacifica
FDA UDI
Seaspine Orthopedics Corporation·10889981088422·Box Cutter 11mm x 17mm
NA
FDA UDI
STERILMED, INC.·10888551017121·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKER...
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002
FDA 510(k)
FDA Class 2
·Cardiovascular
DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MONOCRYL PLUS ANTIBACTERIAL SUTURES
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAN·January 29, 2013
GUARDWIRE PLUS RX-JAPAN
FDA Adverse Event
Malfunction
·MEDTRONIC INC·Product code NFA·December 3, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 2014
PS TIBIAL INSERTS SZ 4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 14, 2023
CC FEMORAL SZ 3
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 10, 2024
CEMENTED FINNED TIB. TRA SZ 3F/3T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 19, 2024
VERSA-DIAL 54X24X58 HUM HEAD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBF·July 28, 2017
OPTETRAK KNEE SYSTEM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 23, 2024
OPTETRAK KNEE COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 29, 2024
PS TIBIAL INSERTS SZ 2, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 13, 2025
CC TIBIAL INSERT SZ 4, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 4, 2024
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Recall
Open, Classified
·Exactech, Inc.·Product code JWH·August 30, 2021