20 results · 27ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Novo Surgical Inc.

FDA UDI
NOVO SURGICAL, INC.·00842331155765·adson-micro thumb forceps, tissue forceps, 1x2 ...

LITE PELVIC FLOOR REPAIR KITS

FDA 510(k)
FDA Class 3 ·Obstetrics/Gynecology

APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM

FDA 510(k)
FDA Class 2 ·Orthopedic

HEARTSTART MRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 5, 2013

RADIAL JAW¿ 3

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·July 23, 2011

ONE TOUCH ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·September 23, 2008

MAX PRI TIB BRNG 14X79/83

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 1, 2019

MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 LONG HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code OVD·December 19, 2022

ELITE IQ

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 4, 2024

ELITE IQ

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 6, 2024

ELITE IQ

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 25, 2025

ELITE IQ

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·September 21, 2021

ELITE IQ

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·April 21, 2026

ELITE IQ

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·December 17, 2021

ELITE IQ

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·April 13, 2022

ELITE IQ

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·September 16, 2025

ELITE IQ

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 20, 2022

ELITE IQ

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 4, 2022

Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

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