87 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Oasis Corneal Marking Pad, REF 0441, Rx only, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 500, B129382391. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.
FDA Recall
Terminated
·Steris Corporation·Product code FTD·February 23, 2010
Walcott Rx Products, Surgical Division, Corneal Marking Pad, REF RX40490, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
GE Healthcare, Innova 3100 IQ : GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
FDA Recall
Terminated
·Ge Healthcare, Llc·Product code MQB·March 24, 2010
Eagle Labs Corneal Marking Pad, Gentian Violet, REF 63-001, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
FDA Recall
Terminated
·Ge Healthcare, Llc·Product code MQB·March 24, 2010
GE Healthcare, Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
FDA Recall
Terminated
·Ge Healthcare, Llc·Product code MQB·March 24, 2010
CYNACON OcuSOFT LASIK Marker Pads, REF 750-093, Rx Only, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-01 Intended use: The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.
FDA Recall
Terminated
·Advanced Bionics Corporation
12740 San Fernando Rd
Bldgs. 1 & 3
Sylmar CA 91342·Product code MCM·November 23, 2010
Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-02H The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.
FDA Recall
Terminated
·Advanced Bionics Corporation
12740 San Fernando Rd
Bldgs. 1 & 3
Sylmar CA 91342·Product code MCM·November 23, 2010
The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.
FDA Recall
Terminated
·Cambridge Heart, Inc.·Product code DRX·April 29, 2010
Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code HWC·March 23, 2010
EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5
FDA Recall
Terminated
·Hospira, Inc.·Product code DNN·July 26, 2010
Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; Sterile, TI Alloy, Implant; Catalog number 3225-0360S. Stryker Trauma GmbH, 24232 Schenjrchen, Germany; distributed in USA by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. Intended for temporary fixation, correction, or stabilization of the right femur.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code HSB·July 23, 2010
Cylindrical Bullet Nose Reamer 14.0 mm x 250 mm, REF 475816, Biomet Orthopedics 66 East Bell Drive Warsaw IN. The product is used to prepare the femoral canal for stem implantation.
FDA Recall
Terminated
·Biomet, Inc.·Product code HTO·December 23, 2010
Cylindrical Bullet Nose Reamer 8.0 mm x 250 mm, REF 475804, Biomet Orthopedics 66 East Bell Drive Warsaw IN. The product is used to prepare the femoral canal for stem implantation.
FDA Recall
Terminated
·Biomet, Inc.·Product code HTO·December 23, 2010
EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DSY·March 26, 2010
Cylindrical Bullet Nose Reamer 15.0 mm x 250 mm, REF 475818, Biomet Orthopedics 66 East Bell Drive Warsaw IN. The product is used to prepare the femoral canal for stem implantation.
FDA Recall
Terminated
·Biomet, Inc.·Product code HTO·December 23, 2010