9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HOOK SURGICAL INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471155978·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 230mm
MTP CLEARVISION DISPOSABLE TUBING SET
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DEPUY M-SPEC 36MM FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LGW·February 21, 2023
PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL, LTD·Product code BTO·December 6, 2010
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 17, 2013
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·July 8, 2014
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