10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020
DEFIBRILLATOR ANALYZER - DA-2006P
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·December 23, 2015
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·November 30, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 2, 2014
STAIR PRO - MODEL 6252
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·December 19, 2012
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code DYB·November 23, 2015
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024