14 results · 29ms · Sources: EU EUDAMED, US FDA

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TRYPTIC SOY BROTH W/C02,SPS&1% YEAST EXT

FDA 510(k)
FDA Class 1 ·Microbiology

MGB Alert Internal Control Set IC1 -48rxn

FDA UDI
Elitechgroup Mdx LLC·03661540951589·The MGB Alert Internal Control Set IC1 consists...

MGB Alert Internal Control Set IC1, 09N39-001

FDA UDI
Elitechgroup Mdx LLC·03661540950155·The MGB Alert Internal Control Set IC1 consists...

ACUMED

FDA UDI
Acumed LLC·10806378042096·LE Mod System Tray Drills and Drivers

NAR Kit

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209101061·KIT, BELT TRAUMA - COMPLETE

FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY

FDA 510(k)
FDA Class 2 ·Cardiovascular

WATCH-PAT MODEL 100S-2

FDA 510(k)
FDA Class 2 ·Anesthesiology

RESTORE SENSOR

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 8, 2014

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·October 22, 2012

INTEGRATED APD SET W/CASSETTE3-PRONG

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 16, 2010

PINNACLE 100 ACET CUP 54MM

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 9, 2011

CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM, 8F, 60CM

FDA Adverse Event
Malfunction ·CONTRACT MEDICAL INTERNATIONAL GMBH·Product code DYB·March 28, 2025

CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM, 8F, 60CM

FDA Adverse Event
Malfunction ·CONTRACT MEDICAL INTERNATIONAL GMBH·Product code DYB·March 28, 2025

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021