14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NA
FDA UDI
Synthes GmbH·10886982152077·3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...
Posterior Pelvic Wall Plate, Right
FDA UDI
I.T.S. GmbH·09120047302255·Posterior Pelvic Wall Plate, Right, 6-Hole, PRS...
Stryker
FDA UDI
Provision·B504TQ59212121360·
Color Cuff
FDA UDI
STRYKER CORPORATION·07613154599707·Disposable Tourniquet Cuff Single Bladder, Sing...
TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
CADD
FDA UDI
ICU MEDICAL, INC.·10610586041327·
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 29, 2014
4 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 8, 2011
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system 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.·August 5, 2015
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025