18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arrow Epidural Catheter Kit
FDA 510(k)
FDA Class 2
·Anesthesiology
BD SYRINGE 1ML S/T W/NDL 27X1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 23, 2024
BD SYRINGE 1ML S/T W/NDL 27X1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 14, 2024
BD SYRINGE 1ML S/T W/NDL 27X1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 23, 2024
BD SYRINGE 1ML S/T W/NDL 27X1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 14, 2024
NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN
FDA 510(k)
FDA Class 2
·Cardiovascular
DUAL LUMEN CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD SYRINGE 1ML S/T W/NDL 27X1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 4, 2024
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 6, 2014
UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·June 3, 2013
2.5MM SETSCREW EXTRACTOR
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·June 3, 2011
PINNACLE SECTOR II CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 20, 2012
SUMMIT POR TAPER SZ5 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 20, 2012
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD·Product code JDI·September 20, 2012
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 20, 2012
BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 18, 2018
Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026