21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vy Spine VyWasher Buttress System
FDA 510(k)
FDA Class 2
·Orthopedic
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROTOCO2L INSUFFLATOR MODEL 6400
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INGEVITY+
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NVN·January 15, 2025
RED LNC-10 PATIENT CABLE
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·October 1, 2014
UNKNOWN DEPUY 28MM DURALOC LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·August 12, 2011
EMAX 2 PLUS HANDPIECE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 9, 2013
UNK KNEE FEMORAL SIGMA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·September 8, 2022
UNKNOWN KNEE FEMORAL ADAPTOR BOLT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·September 8, 2022
UNKNOWN KNEE FEMORAL SLEEVE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·September 8, 2022
UNK KNEE FEMORAL ADAPTOR SIGMA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·September 8, 2022
UNKNOWN KNEE FEMORAL AUGMENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·September 8, 2022
UNK KNEE TIBIAL TRAY SIGMA (RP) MBT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·September 8, 2022
UNKNOWN KNEE TIBIAL SLEEVE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·September 8, 2022
UNK KNEE TIBIAL INSERT SIGMA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·September 8, 2022
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 3, 2021
UNKNOWN KNEE FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JWH·September 8, 2022
UNKNOWN KNEE TIBIAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NJL·September 8, 2022
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 20, 2026