23 results
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20ms
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Sources: EU EUDAMED, US FDA
ENSEAL G2 TISSUS SEALERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...
OmniLab Direct
FDA UDI
Respironics, Inc.·00606959038752·OmniLab Direct
OmniLab Direct
FDA UDI
Respironics, Inc.·00606959044302·OmniLab Direct Software
Fuji
FDA UDI
LANCER ORTHODONTICS, INC.·00817573024438·GC FUJI CAPSULE APPLIER II
Reprocessed 3mm Straight Shaver Blade
FDA UDI
SURETEK MEDICAL·B39062901120331·
PELLO
FDA UDI
STRYKER CORPORATION·07613327576672·3mm Straight Shaver Blade
COMBITRANS MONITORING SETS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
MULTIFUNCTION ENDOSCOPIC INSTRUMENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWI·January 25, 2017
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011
UNK
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 14, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 23, 2014
8MM TI STRAIGHT RADIAL STEM 28MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·January 24, 2017
TRILOGY EVO
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·November 24, 2025
22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·January 24, 2017
18MM COCR RADIAL HEAD STANDARD HEIGHT/11.5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·September 7, 2017
7MM TI STRAIGHT RADIAL STEM 26MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·September 7, 2017
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·December 26, 2013
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026