9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ALVEO-DIFFUSION TEST
FDA 510(k)
FDA Class 2
·Anesthesiology
BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ASAHI Astato XS 40
FDA 510(k)
FDA Class 2
·Cardiovascular
TRULIANT TIB IMP CRC INSERT SZ 5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024
STELLARIS POSTERIOR VITRECTOMY PACK
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQC·April 4, 2014
ARMADA 14 PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·November 30, 2012
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 28, 2010
ASAHI CONQUEST PRO 9-40
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024