22 results · 24ms · Sources: EU EUDAMED, US FDA

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Mapping Suction Probe

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112984·CORNEAL TREPHINE BLADE9.5MM

Origin Stem Size 14 Template

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055936·

MODEL 2121-64; TMJ SURFACE COIL

FDA 510(k)
FDA Class 2 ·Radiology

MR VESSELLQ XPRESS

FDA 510(k)
FDA Class 2 ·Radiology

'RAPIDONE'-METHADONE TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

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

ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·August 15, 2011

DEPUY ASR XL FEM IMP SIZE 45

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 29, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 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

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·April 22, 2025

iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.

FDA Enforcement
Class II ·Terminated·Beckman Coulter Inc.·July 10, 2019