11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OEC One
FDA 510(k)
FDA Class 2
·Radiology
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704511253·BAKES DILATORS 9/SET
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100813·FLIERINGA FIXATION RING 20MM
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702463361·Elvarex 3/Thigh High/Slant, Closed Toe, E-Versi...
Omega Curved Cup Inserter
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215076559·
LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FRONTIER SADL INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 17, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 10, 2014
LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019