15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023888·BAYONETTED PUSH SCRAPER CURETTE
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·December 18, 2014
CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
PRECISION? MONTAGE? MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 30, 2025
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·STRYKER NEUROVASCULAR CORK·Product code HCG·April 22, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 15, 2011
GPS PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FPO·July 3, 2008
ABBOTT TUBE EDTA PLH 13X75 2.0 PNK
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022
ABBOTT TUBE EDTA PLH 13X75 2.0 PNK
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022