18 results · 20ms · Sources: EU EUDAMED, 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