165 results
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30ms
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Sources: EU EUDAMED, US FDA
Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V
FDA Recall
Terminated
·Product code GAM·June 6, 2007
Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
FDA Recall
Terminated
·Gen-Probe Inc·Product code MDK·May 2, 2007
Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.
FDA Recall
Terminated
·Gen-Probe Inc·Product code MDK·December 30, 2008
Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
FDA Recall
Terminated
·Ethicon, Inc. US·Product code LMF·April 3, 2012
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Recall
Terminated
·Oscor, Inc.·Product code IKD·March 31, 2017
Theratron Elite 80 Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron Phoenix Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 780E Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 780C Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron Elite 100 Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 1000E Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 1000 Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for massage and chiropractic treatment.
FDA Recall
Terminated
·MDC Acquisition Co.·Product code FPS·April 23, 2010
TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion
447 March Road
Ottawa Canada Ontario·Product code NAW·February 24, 2009
VariLift Bone Plug w/ End Cap; 13mm Dia, 24mm long; Ref #: CIE1-13-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.
FDA Recall
Terminated
·Product code JDK·September 19, 2007
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
FDA Recall
Terminated
·Biomerieux Inc·Product code MDB·October 16, 2012
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
FDA Recall
Terminated
·Biomerieux Inc·Product code MDB·October 16, 2012
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
FDA Recall
Terminated
·Biomerieux Inc·Product code MDB·October 16, 2012
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Software update for the clinical instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
FDA Recall
Terminated
·Biomerieux Inc·Product code MDB·October 16, 2012
DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantation of a femoral hip prosthesis.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code JDK·January 27, 2011