14 results
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29ms
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Sources: EU EUDAMED, US FDA
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