34 results
·
31ms
·
Sources: EU EUDAMED, US FDA
RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE
FDA 510(k)
FDA Class 1
·Microbiology
Senior Living CareConnect Communicator
FDA UDI
Lifeline Systems Company·00884838081413·CareConnect - Senior Living
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127314·Apex Revision Knee System-Revision Femur Size 4...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690194941·Apex Revision Knee System-Revision Femur Size 4...
BELMONT HYPERTHERMIA PUMP
FDA 510(k)
FDA Class 2
·General Hospital
TAPE MEASURE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SILKAM BLACK 3/0 (2) 75CM HR26
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL SA·Product code GAP·February 11, 2020
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·June 8, 2016
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 7, 2014
COBE SPECTRA TPE SET
FDA Adverse Event
Injury
·CARIDIANBCT·Product code LKN·October 28, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 28, 2012
SILKAM BLACK 2/0 (3) 75CM HS26
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL SA·Product code GAP·February 11, 2020
SILKAM BLACK 3/0 (2) 75CM HR26
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAP·February 27, 2020
SILKAM BLACK 3/0 (2) 75CM HR26
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAP·February 20, 2020
SILKAM BLACK 3/0 (2) 75CM HR26
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAP·February 14, 2020
SILKAM BLACK 0 (3.5) 75CM HS30
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAP·January 7, 2020
SILKAM BLACK 3/0 (2) 75CM HR22
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAP·July 29, 2019
SILKAM BLACK 3/0 (2) 75CM HR22
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAP·July 29, 2019
SILKAM BLACK 3/0 (2) 45CM HS21
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAP·December 28, 2019
SILKAM BLACK 3/0 (2) 75CM HR26
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL SA·Product code GAP·February 26, 2020