15 results
·
24ms
·
Sources: EU EUDAMED, US FDA
GYNECARE PROLENE FASTENER SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809866223·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...
ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·January 23, 2012
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·February 2, 2012
SYMBIQ 3.13 DUAL CHA
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 4, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·April 6, 2011
VITALITY DS
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
IMMULITE 2000 INSULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·January 27, 2012
IMMULITE 2000 INSULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·February 1, 2012
COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-SC-NT
FDA Recall
Terminated
·Cook, Inc.·Product code DYB·November 25, 2002
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015