15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Wearable Digital Thermometer (T31)
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257125908·30-40 MV FOR MEN CLSC CALF STD NAVY III
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123201402·GEMINI CLP 11
VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASCEND
FDA 510(k)
FDA Class 2
·Neurology
Cflex Reduce Full Leg LG LG LG Reg Right Black
FDA UDI
SIGVARIS INC·00745129331740·Inelastic garment (or accessory) made of nylon ...
Cflex Reduce Full Leg LG LG LG Tall Right Black
FDA UDI
SIGVARIS INC·00745129331702·Inelastic garment (or accessory) made of nylon ...
Cflex Reduce Full Leg LG LG LG Reg Left Black
FDA UDI
SIGVARIS INC·00745129331665·Inelastic garment (or accessory) made of nylon ...
Cflex Reduce Full Leg LG LG LG Tall Left Black
FDA UDI
SIGVARIS INC·00745129331627·Inelastic garment (or accessory) made of nylon ...
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 20, 2023
TENDRIL STS
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011
WAGNER SL REVISION
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·October 30, 2014
ON-Q, SILVERSOAKER 5IN:400ML DUAL 2+2 ML/HR
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code BSO·July 18, 2013
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025