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