33 results
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12ms
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Sources: EU EUDAMED, US FDA
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·November 14, 2018
ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·December 3, 2014
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
FDA Enforcement
Class I
·Terminated·Philips Medical Systems (Cleveland) Inc·November 13, 2019
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
FDA Enforcement
Class I
·Terminated·Philips Medical Systems (Cleveland) Inc·November 13, 2019
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
FDA Enforcement
Class I
·Terminated·Philips Medical Systems (Cleveland) Inc·November 13, 2019
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
FDA Enforcement
Class I
·Terminated·Philips Medical Systems (Cleveland) Inc·November 13, 2019
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
FDA Enforcement
Class I
·Terminated·Philips Medical Systems (Cleveland) Inc·November 13, 2019
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
FDA Enforcement
Class II
·Terminated·Organ Recovery Systems, Inc.·February 8, 2017
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Enforcement
Class I
·Terminated·EBI Patient Care, Inc.·May 31, 2017
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Enforcement
Class I
·Terminated·EBI Patient Care, Inc.·May 31, 2017
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. Package Contents Percutaneous Permanent Lead Kits (1) Percutaneous Lead with pre-loaded Curved Stylet (1) Stylet Ring with a Curved and a Straight Stylet (4) Suture Sleeves (1) Insertion Needle with Stylet (1) Lead Blank (1) Steering Cap (1) OR Cable Assembly (2) Lead Position Labelsleft and right (non-sterile) (1) Device Registration Form/Temporary Patient Identification Card (1) Manual
FDA Enforcement
Class II
·Terminated·Boston Scientific Neuromodulation Corporation·June 3, 2020
LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation. Package Contents Percutaneous Permanent Lead Kits (1) Percutaneous Lead with pre-loaded Curved Stylet (1) Stylet Ring with a Curved and a Straight Stylet (4) Suture Sleeves (1) Insertion Needle with Stylet (1) Lead Blank (1) Steering Cap (1) OR Cable Assembly (2) Lead Position Labels left and right (non-sterile) (1) Device Registration Form/Temporary Patient Identification Card (1) Manual
FDA Enforcement
Class II
·Terminated·Boston Scientific Neuromodulation Corporation·June 3, 2020
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
FDA Enforcement
Class II
·Terminated·Med-Mizer, Inc.·May 14, 2014
Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..
FDA Enforcement
Class II
·Terminated·Mar Cor Purification·March 26, 2014
Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
FDA Enforcement
Class II
·Terminated·Mar Cor Purification·March 19, 2014
Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.
FDA Enforcement
Class II
·Terminated·Mar Cor Purification·May 14, 2014
Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage¿ Drug Screen Controls, when used in accordance with the test procedures described in the Alere Triage¿ TOX Drug Screen package insert, provide this capability. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Alere Triage¿ TOX Drug Screen Control 1 or Alere Triage¿ TOX Drug Screen Control 2 consist of human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. 510(k)/IDE/PMA number: K060788 Type of Packaging: 5 vials per level in a labeled kit box. Indications for use: The Alere Triage¿ TOX Drug Screen Controls are to be used with the Alere Triage¿ TOX Drug Screen tests and Alere Triage¿ Meters to assist the laboratory in monitoring test performance.
FDA Enforcement
Class III
·Terminated·Alere San Diego, Inc.·October 30, 2013
LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013
LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.
FDA Enforcement
Class III
·Terminated·Lighthouse For The Blind·April 17, 2013