15 results
·
29ms
·
Sources: EU EUDAMED, US FDA
BTL 799-2T
FDA 510(k)
FDA Class 2
·Physical Medicine
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100967·DESMARRES LID RETRACTOR #1
Stem Pusher
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215069230·
NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 22, 2020
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 9, 2021
1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024
ALARIS SYSTEM
FDA Adverse Event
Injury
·CAREFUSION SD·Product code FRN·December 8, 2025
ALARIS SYSTEM
FDA Adverse Event
Injury
·CAREFUSION SD·Product code FRN·December 8, 2025
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 25, 2016
OPTICROSS?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·October 17, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 21, 2013
GAMMA XL
FDA Adverse Event
Malfunction
·DRAEGER MEDICAL SYSTEMS, INC. (IT/M)·Product code MHX·June 23, 2011
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021