22 results · 23ms · Sources: EU EUDAMED, US FDA

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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