120 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.
FDA Recall
Terminated
·SCC Soft Computer·Product code LNX·July 19, 2010
AOS Trochanteric Nail, 13mm x 20cm x 130, Product Part Number: 1037-200.
FDA Recall
Terminated
·Advanced Orthopaedic Solutions Inc·Product code HSB·January 14, 2010
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.
FDA Recall
Terminated
·Cincinnati Sub-Zero Products Inc·Product code DWJ·October 18, 2010
Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes, REF CC1/P1 Combined Oxygen & Temperature Probe. Contents Sterile and Non-Pyrogenic if package is unopened and undamaged.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GWM·February 18, 2010
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
FDA Recall
Terminated
·Cardima Inc·Product code OCL·May 20, 2010
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
FDA Recall
Terminated
·Cardima Inc·Product code OCL·May 20, 2010
Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.
FDA Recall
Terminated
·Zimmer Inc.·Product code OFY·May 18, 2010
Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by: Preservation Solutions, Inc., Elkhorn, WI 53121. Manufactured for: BTL Solutions LLC, a subsidiary of Bridge to Life, Ltd., 1225 Laurel Street, Columbia, SC 29201.
FDA Recall
Terminated
·Preservation Solutions Inc·Product code KDN·September 24, 2010
SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904008. Used to pass suture through tissue.
FDA Recall
Terminated
·Biomet, Inc.·Product code MDM·June 18, 2010
Suture Lariat 45 Degree Dog Leg Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904025. Used to pass suture through tissue.
FDA Recall
Terminated
·Biomet, Inc.·Product code MDM·June 18, 2010
B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·June 18, 2010
SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904010. Used to pass suture through tissue.
FDA Recall
Terminated
·Biomet, Inc.·Product code MDM·June 18, 2010
Mast Roller Pump, Catalog 50-80-00, for use with Sorin HLM C5 and HLM S5.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·June 18, 2010
Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DWF·June 18, 2010
Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile, Cook Urological, Inc., Spencer IN. Used for temporary internal drainage from the ureteropelvic junction to the bladder.
FDA Recall
Terminated
·Vance Products Incorporated·Product code FAD·October 18, 2010
Suture Lariat 30 Degree Up, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904022. Used to pass suture through tissue.
FDA Recall
Terminated
·Biomet, Inc.·Product code MDM·June 18, 2010
SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Right, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904012. Used to pass suture through tissue.
FDA Recall
Terminated
·Biomet, Inc.·Product code MDM·June 18, 2010
Merit One Step Centesis Drainage Catheter Intended for the percutaneous drainage of fluids
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code gbx·November 17, 2010