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

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RIA KIT, VITAMIN B12

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Dealmed

FDA UDI
DEALMED MEDICAL SUPPLIES LLC·00817415020215·Tongue Depressor Sterile Wood 6" Senior 1's, 10...

Sklar®

FDA UDI
SKLAR CORPORATION·10649111297250·JACKSON TRACH TUBE #4-4 PIECES

KING Snap Lead/DIN Connector

FDA UDI
Kego Corporation·00663427000048·KING Snap Lead/DIN Connector Qty 5 .6 m (24")...

RX LENS SERIES

FDA 510(k)
FDA Class 1 ·Ophthalmic

Dissecting Balloon System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

1020279-2014-00289

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·April 30, 2014

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 5, 2012

HARMONIC ACE 36 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·January 24, 2008

4K C-MNT SCP,4.0,0,167,MITEK

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SàRL·Product code HRX·May 23, 2024

UNKNOWN SOLITAIRE

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·January 8, 2025

UNKNOWN SOLITAIRE

FDA Adverse Event
Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·January 8, 2025

DAVINCI XI

FDA Adverse Event
Injury ·INTUITIVE SURGICAL, INC·Product code NAY·November 12, 2024

OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021