15 results · 24ms · Sources: EU EUDAMED, US FDA

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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