13 results · 31ms · Sources: EU EUDAMED, US FDA

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KINEX BIOACTIVE

FDA 510(k)
FDA Class 2 ·Orthopedic

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780378556·Integra® Jarit® Russian Tissue Forceps, 7-3/4",...

ArgenZ HT+ 98x25 ML A4B

FDA UDI
ARGEN CORPORATION, THE·D818130392·Dental porcelain/ceramic restoration kit

EVONOS

FDA UDI
Gyrus ACMI, LLC·00821925011984·JORDAN PICK 45 DEGREE TIP ANGLE, UP, SLIM .70 M...

EMERGE?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·February 11, 2026

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

SAPPHIRE DETACHABLE COIL SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

COMP LK SCR 3.5HEX 4.75X25 ST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·September 19, 2022

ACCU-CHEK ® COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 24, 2013

SYSTEM 5 SAGITTAL SAW

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·May 9, 2011

SAGB QUICK CLOSE

FDA Adverse Event
Malfunction ·OBTECH MEDICAL SARL·Product code LTI·August 20, 2008

VASO VIEW HEMOPRO

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019

K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080B-N-18T; 1.4mm x 18" Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

FDA Enforcement
Class II ·Terminated·Amendia, Inc·December 28, 2016