19 results · 27ms · Sources: EU EUDAMED, US FDA

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MTX-C1

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Bernafon

FDA UDI
Bernafon AG·05711584114032·CO5 B 105, 2.4G NFM SABE DEMO CAPTO 5 GPL

NUVASIVE COROENT NO-PROFILE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

RAD-97 PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·November 7, 2023

RAD-97 PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 11, 2023

RAD-97 PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 22, 2023

RAD-97 PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023

RAD-97 PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023

DUOVISC

FDA Adverse Event
Injury ·ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.·Product code LZP·October 24, 2008

ECHELON*FLEX60 LONG

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 16, 2011

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 9, 2013

RAD-97 PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·October 11, 2023

RAD-97 PULSE CO-OXIMETER WITH NOMOLINE CAPNOGRAPHY

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 12, 2023

RAD-97 PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 15, 2023

RAD-97 PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 5, 2023

BD SAFETYGLIDE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·February 19, 2020

DRX Revolution Mobile X-Ray System

FDA Enforcement
Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021