14 results
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17ms
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Sources: EU EUDAMED, US FDA
PULMO-AIDE MODEL 5610D
FDA 510(k)
FDA Class 1
·Anesthesiology
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809916496011·Long-arm Multi-Axial Fenestrated Screw, Ø4.5 x ...
RECLAIM
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295533832·RECLAIM MONOBLOC REVISION FEMORAL STEM STANDARD...
RECLAIM
FDA UDI
DEPUY (IRELAND)·10603295517801·RECLAIM MONOBLOC REVISION FEMORAL STEM EXTRA LO...
Symmetry Lister
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482127933·Symmetry® Scissors, Lister Bandage, Serrated, 8 in
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209130467·
Arthrex®
FDA UDI
ARTHREX, INC.·00888867124424·LOW PROFILE SCREW, TI, 4.5 X 20MM
KLIGER IRON AGAR
FDA 510(k)
FDA Class 1
·Microbiology
NEAA-NON-ESSENTIAL AMINO ACIDS
FDA 510(k)
FDA Class 1
·Hematology
Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·March 25, 2020
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 6, 2014
QUADROX-ID
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 29, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 30, 2010
Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.
FDA Recall
Terminated
·Arthrex, Inc.·Product code HWC·October 1, 2019