17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS
FDA Adverse Event
Malfunction
·AESCULAP IMPLANT SYSTEMS·Product code KRO·November 21, 2017
MicroSpot Handpiece
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL
FDA 510(k)
FDA Class 2
·Cardiovascular
AE-QAS-K521-53
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·December 19, 2024
AS COLUMBUS REV F TIB.OFFSET CEMENT.T2+
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·March 20, 2023
AS COLUMBUS REV F FEMUR CEMENTED F4L
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·March 20, 2023
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SWINFORD·Product code KDI·June 5, 2014
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·November 12, 2012
ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·September 29, 2010
COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·June 22, 2021
COLLECT.NO.QAS KNEE IMPLANTS COLUMBUS
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·June 22, 2021
COLUMBUS
FDA Adverse Event
Injury
·AESCULAP AG·Product code OOG·December 1, 2023
COLLECT.NO.QAS KNEE IMPL.MISC./UNKNOWN
FDA Adverse Event
Injury
·AESCULAP AG·Product code JWH·March 5, 2021
COLUMBUS
FDA Adverse Event
Injury
·AESCULAP AG·Product code OOG·December 1, 2023
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025