18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FIT CHECKER ADVANCED
FDA 510(k)
FDA Class 2
·Dental
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306819209·Simpson-St. Mark's Retractor 6" , w/Lip
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964094095·Endo Carry-On Procedure Kit
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964093678·Endo Carry-On Procedure Kit
TRUSIGNAL SPO2 FINGERTIP SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
TGL FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 3, 2020
BD LUER SLIP¿ TUBERCULIN SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMF·February 8, 2018
PENTA
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013
FOLEY CATHETER 16 FR.
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code EZL·September 16, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 2, 2011
SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 27, 2021
BD DISCARDIT¿ II SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·August 13, 2018
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·February 19, 2014
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·February 19, 2014
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024