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Sources: EU EUDAMED, US FDA
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The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.
FDA Enforcement
Class II
·Terminated·Diamedix Corporation·December 5, 2012
Olympus Sterile Optical Laser Fiber, single use and reusable
FDA Enforcement
Class II
·Terminated·Quanta System, S.p.A.·June 16, 2021
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
FDA Recall
Terminated
·Cardiovascular Systems, Inc.·Product code MCW·June 18, 2012
Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
FDA Recall
Terminated
·Instratek, Incorporated·Product code NBH·September 18, 2012
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code NKB·June 18, 2012
The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty. The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on 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 device is intended for either cemented or noncemented use.
FDA Recall
Terminated
·Zimmer Inc.·Product code JDI·September 1, 2011
Sunrise Medical Zippie TS wheelchair To empower physically challenged person by providing a means or mobility.
FDA Recall
Terminated
·Sunrise Medical (US) LLC·Product code IOR·January 13, 2012
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
FDA Recall
Terminated
·Iris Diagnostics·Product code JJW·September 18, 2012
ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code LOM·December 18, 2012
Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
FDA Recall
Terminated
·Pharmaceutical Innovations, Inc.·Product code MUI·March 2, 2012
Other-Sonic Generic Ultrasound Transmission Gel 250 mL Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
FDA Recall
Terminated
·Pharmaceutical Innovations, Inc.·Product code MUI·March 2, 2012
Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code NJR·September 18, 2012
Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
FDA Recall
Terminated
·Cardinal Health·Product code FSM·December 18, 2012
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
FDA Recall
Terminated
·Cardinal Health·Product code FSM·December 18, 2012
Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
FDA Recall
Terminated
·Cardinal Health·Product code FSM·December 18, 2012
Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA) Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area; (Cat. No. 3FM70SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
FDA Recall
Terminated
·Cardinal Health·Product code FSM·December 18, 2012
Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. Product Usage: For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Exchange. Internationally, this device is approved for use in Mono Nucleo Cell engraftment.
FDA Recall
Terminated
·CaridianBCT, Inc.·Product code LKN·May 4, 2012
Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. The following products being recalled: Imager" II Catheters C1 5fr 65cm M0064003001 M0064003000 400-300 Imager" II Catheters C2 5fr 65cm M0064003011 M0064003010 Catalog # 400-301 Imager" II Catheters Straight 5fr 65cm M0064003021 M0064003020 Catalog #400-302 Imager" II Catheters Bern 5fr 65cm M0064003031 M0064003030 Catalog #400-303 Imager" II Catheters JB1 5fr 65cm M0064003041 M0064003040 Catalog #400-304 Imager" II Catheters Straight 5fr 100cm M0064004021 M0064004020 Catalog #400-402 Imager" II Catheters Bern 5fr 100cm M0064004031 M0064004030 Catalog #400-403 Imager" II Catheters JB1 5fr 100cm M0064004041 M0064004040 Catalog #400-404 Imager" II Catheters Bern 5fr 40cm M0064005031 M0064005030 Catalog #400-503 The Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop", intended for use in the urinary tract.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code KOD·March 15, 2012
Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
FDA Recall
Terminated
·Exactech, Inc.·Product code KWS·June 15, 2012
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA40SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM40SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
FDA Recall
Terminated
·Cardinal Health·Product code FSM·December 18, 2012