14 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
FDA 510(k)
FDA Class 2
·Orthopedic
PRESTIGE® Cervical Disc System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902723223·PRESTIGE ARTIFICIAL DISC 6X12MM
P.F.C. SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295236481·P.F.C. SIGMA POSTERIOR-LIPPED TIBIAL INSERT TRI...
INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARIZONA OXYGEN TIMER DEVICE
FDA 510(k)
FDA Class 1
·Anesthesiology
PFCSIG POSTLIP TRIAL 8MM SZ5
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code HWT·April 29, 2022
SP*2 FEMORAL IMPACTOR
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code HWA·April 29, 2022
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 14, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·December 21, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 28, 2014
COMPRESSION FORCEPS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWN·February 3, 2021
PFCSIGMA INS TRL STABL 8MM SZ4
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code HWT·April 29, 2022
SP2 TIBIAL RADEL IMPACTOR
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code HWA·April 29, 2022
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024