13 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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REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036028114·
Nitinol Stone Extractor, helical basket, 4 wires, 2.5 Fr, 90cm
FDA UDI
Promepla·03700512967736·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776363307·Lucas Curette
TRI-FIT FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
LASERPRO 16
FDA 510(k)
FDA Class 2
·Radiology
VERSAFITCUP ACETABULAR SHELL Ø52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·August 31, 2016
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013
IMMERSION HYDROBATH
FDA Adverse Event
Malfunction
·INVACARE CLEVELAND STREET·Product code ILJ·September 15, 2014
UNKNOWN THREADED PEG
FDA Adverse Event
Injury
·HAND INNOVATIONS LLC·Product code HWC·July 30, 2008
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 10, 2022
VERSAFITCUP ACETABULAR SHELL Ø 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·October 21, 2016
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024