20 results · 23ms · Sources: EU EUDAMED, US FDA

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Promisemed Safety Huber Needle

FDA 510(k)
FDA Class 2 ·General Hospital

Plateau-V Spacer System

FDA UDI
Life Spine, Inc.·00190837029104·PLATEAU-V Interbody, Straight, Bulleted, 12mm x...

21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

FDA Adverse Event
Injury ·BECTON, DICKINSON & CO., (BD)·Product code FMI·January 26, 2016

SOLETRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 5, 2012

RoughRider Aurora Manual Wheelchair

FDA 510(k)
FDA Class 1 ·Physical Medicine

SAFFRON NM GUIDING CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SOLETRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 17, 2012

SOLETRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 17, 2012

ISPAN PERFLUOROPROPANE (C3F8) GAS

FDA Adverse Event
Injury ·ALCON - FORT WORTH/ALCON LABORATORIES, INC.·Product code LPO·August 17, 2011

CUSTOM COMBI SET

FDA Adverse Event
Malfunction ·REYNOSA PLANT·Product code FJK·October 22, 2014

KOTEX NATURAL BALANCE

FDA Adverse Event
Malfunction ·KIMBERLY-CLARK CORPORATION - CONWAY MILL·Product code HEB·July 17, 2013

BD RAPID DETECTION OF SARS-COV-2 VERITOR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·November 23, 2020

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 19, 2012

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 10, 2013

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020