14 results · 20ms · Sources: EU EUDAMED, US FDA

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InferRead Lung CT.AI

FDA 510(k)
FDA Class 2 ·Radiology

EarQ

FDA UDI
Sbo Hearing A/S·05714464056408·EARQ F10 MINIRITE T C090 DEMO

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017996·K-Wire, Single Ended, Trocar Point, Diameter Si...

ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256

FDA 510(k)
FDA Class 2 ·Neurology

IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Tontarra Medizintechnik GmbH

FDA UDI
Tontarra Medizintechnik GmbH·04050183356476·PITUITARY Rongeur straight; 4mm width; coated 2...

Tontarra Medizintechnik GmbH

FDA UDI
Tontarra Medizintechnik GmbH·04050183356483·PITUITARY Rongeur straight; 6mm width; coated 2...

Tontarra Medizintechnik GmbH

FDA UDI
Tontarra Medizintechnik GmbH·04050183356469·PITUITARY Rongeur straight; 2mm width; coated 2...

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

COROX OTW-S 85-BP

FDA Adverse Event
Injury ·BIOTRONIK SE & CO. KG·Product code OJX·November 10, 2014

TENDRIL STS

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011

PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE

FDA Adverse Event
Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DYB·July 22, 2013

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025