13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FEops HEARTguide
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Synthes GmbH·10886982153654·4.5MM CORTEX SCREW 66MM
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551114055·HALO, CTLSO VEST SMALL, ACRYLIC LINER, 1201-1 X...
Deltec
FDA UDI
ICU MEDICAL, INC.·10610586039904·
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ImagePilot
FDA 510(k)
FDA Class 2
·Radiology
LOCKING SCREW, FULLY THREADED 5X45 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 30, 2009
INVICTUS
FDA Adverse Event
Injury
·ALPHATEC SPINE, INC.·Product code NKB·November 21, 2024
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 24, 2014
GREENLIGHT PV ADDSTAT
FDA Adverse Event
Other
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·August 2, 2011
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·July 9, 2013
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
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