10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BH Medical Dental Barrier Sleeves and Barrier Film
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Oticon
FDA UDI
Oticon A/S·05707131338891·SIYA 1, BTE 13 PP 2.4G 105 C092
ALICE PDX
FDA 510(k)
FDA Class 2
·Anesthesiology
IMPIX MANTA CERVICAL INTERBODY DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
MCLEAN-RING NASOJEJUNAL FEEDING TUBE SET
FDA Adverse Event
Injury
·COOK INC·Product code KNT·November 10, 2021
MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code KNW·October 9, 2008
POWER PRO AMBULANCE COT
FDA Adverse Event
Injury
·STRYKER MEDICAL·Product code INK·July 29, 2011
SCRDRIVER F/CLICKX LOCKCAP SELF-HOLD W/T
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·June 26, 2013
ADVANCED PATELLA 35MM 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 9, 2024
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