256 results
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14ms
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Sources: EU EUDAMED, US FDA
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
FDA Recall
Terminated
·Abiomed, Inc.·Product code OZD·September 4, 2019
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
FDA Recall
Terminated
·Abiomed, Inc.·Product code OZD·March 1, 2021
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
FDA Recall
Terminated
·Abiomed, Inc.·Product code OZD·October 10, 2023
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
FDA Recall
Terminated
·Abiomed, Inc.·Product code OZD·October 10, 2023
VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD); Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA); Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip (COC-THC-OPI-BZD-OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.
FDA Recall
Terminated
·Sun Biomedical Laboratories, Inc.·Product code DJR·May 28, 2008
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
FDA Recall
Terminated
·Biomet, Inc.·Product code LPH·April 26, 2013
Viasys, REF BLD-1000, Pulmanex Adapter 22mm O.D. x 22mm O.D. x 15 mm I.D., manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
FDA Recall
Terminated
·Unomedical, Inc·Product code BZA·December 2, 2004
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
FDA Recall
Terminated
·Smith & Nephew Inc·Product code MRA·March 11, 2011
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
FDA Recall
Terminated
·Smith & Nephew Inc·Product code MRA·March 11, 2011
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 52 MM O.D., REF 71338952, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
FDA Recall
Terminated
·Smith & Nephew Inc·Product code MRA·March 11, 2011
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 56 MM O.D., REF 71338956, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
FDA Recall
Terminated
·Smith & Nephew Inc·Product code MRA·March 11, 2011
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
FDA Recall
Terminated
·Smith & Nephew Inc·Product code MRA·March 11, 2011
Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual Spray MiniSpacer with Counter Incrementing Actuator is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The design of the actuator component of REF 1543A has been enhanced by the addition of a linear gear designed to increment the dose-counter on some pMDI canisters. REF 1543A provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs the medication through the dual orifices into the airstream
FDA Recall
Terminated
·Thayer Medical Corporation·Product code CAF·September 29, 2016
The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused Hip, fracture of the pelvis, and diastrophic variant. The shells with screw holes permit the use of titanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient.
FDA Recall
Terminated
·Zimmer, Inc.·Product code LPH·September 20, 2012
DrugCheck 8 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP Product Code 60800
FDA Recall
Terminated
·Drug Free Enterprises Inc·Product code DIO·March 20, 2003
Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 130 mm; REF 67HA80.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code JOH·December 16, 2005
DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/TCA Product Code 60900
FDA Recall
Terminated
·Drug Free Enterprises Inc·Product code DIO·March 20, 2003
DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/MTD Product Code 60925
FDA Recall
Terminated
·Drug Free Enterprises Inc·Product code DIO·March 20, 2003
Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 mm; REF 75HA60.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code JOH·December 16, 2005
Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code JOH·December 16, 2005