11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776325602·Biopsy And Grasping Forcep,
Infrared Thermometer Model Number RN-50A,RN-50B
FDA 510(k)
FDA Class 2
·General Hospital
BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIVONA® TTS¿ 8.0MM TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·May 15, 2017
PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·May 31, 2017
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 1, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·July 16, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025