13 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
Xenon Rebreathing System
FDA UDI
BIODEX MEDICAL SYSTEMS, INC.·00718175005019·KIT, XENON CNVC, FACE MASK, BATERIA FILTER AND ...
KONICA LASER IMAGER, MODEL DRYPRO MODEL 771
FDA 510(k)
FDA Class 2
·Radiology
ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
FDA 510(k)
FDA Class 2
·Microbiology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 31, 2024
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 29, 2013
AO/ASIF-QC F/BPL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code GEY·October 1, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 17, 2011
5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 48MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·October 18, 2018
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·July 2, 2020
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·July 2, 2020
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015