22 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ
FDA 510(k)
FDA Class 2
·Physical Medicine
CONMED
FDA Adverse Event
Other
·CONMED ELECTROSURGERY·Product code GEI·April 11, 2007
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001191313090·Bullet Trial, 13 mm AH - 09 mm PH
EXELINT ALUMINUM HUB BLUNT NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320
FDA 510(k)
FDA Class 2
·Physical Medicine
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 13, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·October 1, 2014
PELVICOL 4 X 12 CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES·Product code FTL·May 17, 2013
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·June 16, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·November 3, 2021
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 29, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·December 26, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 4, 2020
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·May 31, 2019
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
FDA Enforcement
Class II
·Terminated·Cyberonics, Inc·December 31, 2014
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;
FDA Enforcement
Class II
·Ongoing·Implant Direct Sybron Manufacturing LLC·July 5, 2023
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·April 7, 2021
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·November 30, 2021
EQUINOXE ANATOMIC SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·May 22, 2025