20 results
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44ms
·
Sources: EU EUDAMED, US FDA
LORENZ MANDIBULAR DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704287103·
SOLID CORE GUTTA PERCHA CARRIER
FDA 510(k)
FDA Class 1
·Dental
VOYAGR SERIES OF DEFLECTABLE DIAGOSTIC EP CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOTRACHEAL TUBE 7.5 MM EMG FLEX
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code BTR·July 28, 2010
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code ETN·December 16, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCORE PURITAN BENNETT IRELAND·Product code CBK·June 11, 2014
ADAPTA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·February 11, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 10, 2011
ENDOTRACH TUBE 8229306J NIM EMG 6MM
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC·Product code ETN·March 6, 2013
ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·May 10, 2013
ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code ETN·March 11, 2013
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·August 26, 2013
VIDAS ESTRADIOL II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CHP·January 21, 2021
ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·February 11, 2013
NIM® EMG - ENDOTRACHEAL TUBE - NIM FLEX¿
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code ETN·October 18, 2021
VIDAS® ESTRADIOL II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CHP·September 16, 2021
MAINFRAME 8253001 NIM RESPONSE 3.0
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·August 28, 2013
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 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 Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021