12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032698·Baltic Denture System BDLoad Mm6 PLSEbim6DFm BL...
TRIO LX SMALL CONNECTOR
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011
SCOOTER MARS SERIES, MODEL TL-588
FDA 510(k)
FDA Class 2
·Physical Medicine
VANGUARD REPROCESSED PHACOEMULSIFICATION
FDA 510(k)
FDA Class 2
·Ophthalmic
NELLCOR N20
FDA Adverse Event
Malfunction
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code DQA·March 29, 2013
ANEURX XPEDIENT STENT GRAFT (FLEXIBLE HD) SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR·Product code MIH·March 25, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 22, 2008
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026