15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·07613327253436·MCK PF METAL INS TRAY LID
Oticon
FDA UDI
Oticon A/S·05707131285980·NERA2 PRO TI, RITE 312 WL CBE
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120465·Guidewire 0.9x150mm Dbl Trocar
STATION,DUAL LATCHING,UNIVERSAL,3 GANG
FDA UDI
Crest Healthcare Supply·B48411500930·STATION,DUAL LATCHING,UNIVERSAL,3 GANG
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100035·BARRAQUER HEAVY WIRE SPECULUM LARGE
VSI TORQUE DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES GRENCHEN·Product code HRS·January 30, 2017
PANEL PHOENIX NMIC/ID-307
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024
LOGIC FEMORAL PS CEM LEFT SZ 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 18, 2022
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011
DUROM HIP
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·June 3, 2013
KINECTIV TECHNOLOGY NECK PROVISIONAL
FDA Adverse Event
Malfunction
·ZIMMER INC.·Product code LXH·August 29, 2008
Philips DuraDiagnost stationary X-ray system
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·September 7, 2016