16 results
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35ms
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Sources: EU EUDAMED, US FDA
STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PRESTIGE® Cervical Disc System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902451959·SCREW 6960120 LOCK
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295232742·P.F.C. SIGMA INSET PATELLA 25mm CEMENTED
Eye Shield
FDA UDI
KATENA PRODUCTS, INC.·00841668111130·EYE SHIELD W/ GARTER ASSORTED PACK OF 50
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955937552·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955939891·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955938726·Percutaneous Transluminal Angioplasty Balloon C...
BD PURPREP
FDA Adverse Event
Malfunction
·CAREFUSION 213, LLC 0113·Product code KXG·October 20, 2021
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
D-SPECT Processing and Reviewing Workstation
FDA 510(k)
FDA Class 2
·Radiology
Anti-SARS-CoV-2 S1 Curve ELISA (IgG)
FDA UDI
EUROIMMUN Medizinische Labordiagnostika AG·04049016150244·
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 13, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 17, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 28, 2014
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017