18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
FDA 510(k)
FDA Class 2
·Hematology
Disc Prep
FDA UDI
Life Spine, Inc.·00190837089870·
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
MACHNET CAROTIDS COIL ARRAY ASSEMBLY
FDA 510(k)
FDA Class 2
·Radiology
BACKSTOP CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·May 14, 2013
VECTRA GENISYS 2CH COMBO PKG
FDA Adverse Event
DJ ORTHOPEDICS DE MEXICO·Product code IMG·March 29, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·March 8, 2012
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·March 8, 2012
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·March 8, 2012
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·March 8, 2012
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·March 8, 2012
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·March 8, 2012
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
FDA Enforcement
Class II
·Terminated·Medrad Inc·February 27, 2013
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024