9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex SS VAL and VAL KreuLock Compression Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
NEO IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)
FDA 510(k)
FDA Class 2
·Cardiovascular
CLINITEK STATUS+
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code JIL·May 16, 2016
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code CHL·March 4, 2025
DEXTRUS 4136
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO.·Product code DTB·November 10, 2008
GYNNIE OB-GYN STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·September 1, 2011
PERSONA VE ARTICULAR SURFACE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·July 19, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025