13 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLIGHT 60 VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ArgenZ ST 98x12 ML OM2B
FDA UDI
ARGEN CORPORATION, THE·D818130171·Dental porcelain/ceramic restoration kit
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925013490·ANTOLI-CANDELA 45 DEGREE PICK-1.5 MM
Accent Mini
FDA UDI
ORMCO CORPORATION·00889989003321·U7L ACCENT MINI DAMON 22 -27/0/6
ELECSYS ANTI-TPO CALSET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
FDA 510(k)
FDA Class 2
·Dental
POWERPACK
FDA Adverse Event
Malfunction
·ICC-NEXERGY·Product code IYN·September 3, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 24, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 30, 2014
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
FDA Enforcement
Class II
·Terminated·Ecolab Inc·February 19, 2014
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
FDA Enforcement
Class II
·Terminated·Ecolab Inc·February 19, 2014
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015