10 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)
FDA 510(k)
FDA Class 2
·Orthopedic
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·May 23, 2023
Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 12, 2018
TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·April 24, 2023
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
X8000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·November 23, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 3, 2014
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026