22 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
FDA 510(k)
FDA Class 1
·General Hospital
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033683·Baltic Denture System BDLoad BDLoad ↓ Lw6 PLSEu...
BD SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 17, 2018
BD SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 17, 2018
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AVANTE CURELIGHT
FDA 510(k)
FDA Class 2
·Dental
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code LKK·April 3, 2013
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·March 17, 2011
ICY HOT HEAT THERAPY PATCH
FDA Adverse Event
Other
·CHATTEM, INC.·Product code IMD·April 22, 2008
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQO·March 5, 2024
TERUMO PROGREAT CATHETER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·February 6, 2023
PROGREAT CATHETER
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQO·January 6, 2024
PROGREAT
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQO·April 15, 2025
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·November 1, 2022
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 16, 2022
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 30, 2021
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Recall
Open, Classified
·Exactech, Inc.·Product code JWH·August 30, 2021
Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 17, 2019
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
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021