207 results
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13ms
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Sources: EU EUDAMED, US FDA
Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery.
FDA Recall
Terminated
·NOVADAQ TECHNOLOGIES INC.·Product code IZI·August 18, 2016
Cook Polyvinyl Alcohol Foam (PVA ) Embolization Particles, particle size 47-90 microns, 1 cc; order number PVA-50.
FDA Recall
Terminated
·Cook, Inc.·July 1, 2003
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 180-300 microns, 1 cc; order number PVA-200.
FDA Recall
Terminated
·Cook, Inc.·July 1, 2003
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 710-1000 microns, 1 cc; order number PVA-700.
FDA Recall
Terminated
·Cook, Inc.·July 1, 2003
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 300-500 microns, 1 cc; order number PVA-300.
FDA Recall
Terminated
·Cook, Inc.·July 1, 2003
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 500-710 microns, 1 cc; order number PVA-500.
FDA Recall
Terminated
·Cook, Inc.·July 1, 2003
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 90-180 microns, 1 cc; order number PVA-100.
FDA Recall
Terminated
·Cook, Inc.·July 1, 2003
Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code OVE·September 30, 2013
PVA Foam Surgical Spears Catalog #: OASIS0525
FDA Recall
Terminated
·Ultracell Medical Technologies·Product code HOZ·January 8, 2003
Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye, ocucel, 5S, PVA, 1 cover, support, tray 2.2MIL 6FD, and 2 dressings, tegaderm, 2 3/8 x 2 3/4. All contents considered sterile unless package is opened or damaged.RX Only. Part number 10162-01. (The Vidaurri LASIK Flap Irrigators are included in the firm''s Alcon Custom Pak Part Number 10162-01 under the description of dual tip irrigator, 8 ports, 16G.)
FDA Recall
Terminated
·Alcon Research, Ltd·Product code LQJ·September 2, 2005
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes
FDA Recall
Terminated
·Abbott Molecular, Inc.·Product code OVQ·August 4, 2021
NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.
FDA Recall
Terminated
·NOVADAQ TECHNOLOGIES INC.·Product code MMP·June 27, 2017
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number AC2029 (Reorder No. 21-0330-01) Speciality Administration Low Adsorption Filter Set has 105 inch length/267 cm, 27.5ml priming volume, 20 drops/ml, 0 injection sites, 0.22 micron air-eliminating filter, PVC Cassette, non-PVC lined tubing, non-PVC drip chamber.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004
Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" PVC w/trocar, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-5390-040-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 3/16" PVC w/trocar, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2505-000-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 1/8" PVC w/trocar, 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2500-000-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 1/8" PVC w/trocar, 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2500-700-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 3/32" PVC w/trocar, 2,4mm, 7Fr, PVC, 107cm, small, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2595-000-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 3/16" PVC w/trocar, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2505-700-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008
Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 1/4" PVC w/trocar, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2590-040-10.
FDA Recall
Terminated
·Zimmer Inc.·Product code GCY·January 29, 2008