14 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Oticon
FDA UDI
Oticon A/S·05707131271327·ALTA PRO, KIT 10 WL OMNI 75 BE
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037251·Unitek(TM) Bicuspid Band General Purpose Wide L...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515019072·Carmalt Artery Fcps, str, 9" (23cm)
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 3, 2021
HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
COAXIAL INTRODUCER SET
FDA 510(k)
FDA Class 2
·Cardiovascular
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776391515·Curved Elevator, 13mm
XCELA
FDA Adverse Event
Malfunction
·PFM MEDICAL CPP SA·Product code LJT·June 23, 2022
ADVIA CENTAUR XPT
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·July 19, 2016
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 1, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025