11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Screw Holding Forceps - Long (SG 1109)
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215083441·
BD INTEGRA¿ SYRINGE W/ DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·January 28, 2020
AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
FDA 510(k)
FDA Class 2
·Cardiovascular
EZ-JECT
FDA 510(k)
FDA Class 2
·General Hospital
E SERIES DEFIBRILLATOR
FDA Adverse Event
Death
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 2, 2008
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 10, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 29, 2013
BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·February 13, 2020
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·May 18, 2016
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024