25 results · 21ms · Sources: EU EUDAMED, US FDA

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CHAD THERAPEUTICS OXYMATIC MODEL 401

FDA 510(k)
FDA Class 2 ·Anesthesiology

Preat

FDA UDI
Preat Corporation·00842092183847·ASC NobelActive?/Conical-compatible NP X 9mm En...

Preclean Kit

FDA UDI
MEDIVATORS INC.·40677964007604·Preclean Plus Kit includes DEFENDO Air/Water Su...

Truliant

FDA UDI
Exactech, Inc.·10885862623706·Special Truliant DF FFG Uncaptured Anterior and...

FlowLogic Assert

FDA UDI
SONENDO, INC.·00810209421342·FlowLogic Assert Shaping File Variable Kit, 21mm

TRUSTEEL

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·August 22, 2024

MODIFICATION TO CARTO EP NAVIGATION SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

TISSUE LEVEL DENTAL IMPLANT RP Ø3.3 L10

FDA Adverse Event
Injury ·HAGER & MEISINGER GMBH·Product code DZE·September 27, 2023

TRUSTEEL

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·August 9, 2024

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 11, 2024

NA

FDA UDI
Zimmer, Inc.·00889024024441·

NA

FDA UDI
Zimmer, Inc.·00889024024458·

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·February 24, 2011

ARCHITECT C8000

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·February 21, 2008

ECC.O SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL

FDA Adverse Event
SORIN GROUP ITALIA·Product code KFM·February 29, 2016

C8XX2, GELPORT 120MM

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·April 11, 2022

C8XX2, GELPORT 120MM

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·April 7, 2022

PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.

FDA Enforcement
Class II ·Terminated·PTW-Freiburg·September 2, 2015