68 results
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7ms
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Sources: EU EUDAMED, US FDA
PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
FDA Enforcement
Class III
·Terminated·Laurimed LLC·May 7, 2014
Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.
FDA Enforcement
Class III
·Terminated·Covidien LLC·May 22, 2013
Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.
FDA Enforcement
Class III
·Terminated·Covidien LLC·May 22, 2013
20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
FDA Enforcement
Class III
·Terminated·CellEra LLC·March 23, 2022
20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
FDA Enforcement
Class III
·Terminated·CellEra LLC·March 23, 2022
20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
FDA Enforcement
Class III
·Terminated·CellEra LLC·March 23, 2022
20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
FDA Enforcement
Class III
·Terminated·CellEra LLC·March 23, 2022
20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
FDA Enforcement
Class III
·Terminated·CellEra LLC·March 23, 2022
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended for professional use only. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas: kidney function, urinary tract infections, carbohydrate metabolism (e.g. diabetes mellitus), liver function, acid-base balance and urine concentration. The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The Clarity 10SG Urinalysis Reagent Strips (Urine) can be read visually , on the Clarity Urocheck 120 Urine Analyzers , and on the Clarity Urocheck 120C Urine Analyzers.
FDA Enforcement
Class III
·Terminated·Clarity Diagnostics Llc·August 22, 2018
D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.
FDA Enforcement
Class III
·Terminated·Biocare Medical, LLC·June 3, 2015
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
FDA Enforcement
Class III
·Terminated·CareFusion 213, LLC·April 3, 2013
ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.
FDA Enforcement
Class III
·Terminated·Biomet 3i, LLC·March 26, 2014
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
FDA Enforcement
Class III
·Terminated·Advanced Bionics, LLC·February 26, 2020
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
FDA Enforcement
Class III
·Terminated·DeVilbiss Healthcare LLC·July 9, 2014
BIOPHEN UFH Control Plasma
FDA Enforcement
Class III
·Terminated·Aniara Diagnostica LLC·September 21, 2022
BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.
FDA Enforcement
Class III
·Terminated·Helix Medical LLC·September 19, 2012
Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
FDA Enforcement
Class III
·Terminated·Viscot Medical LLC·April 10, 2013
Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
FDA Enforcement
Class III
·Terminated·Biocare Medical, LLC·April 27, 2016
Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures.
FDA Enforcement
Class III
·Terminated·Edwards Lifesciences, LLC·January 1, 2014
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
FDA Enforcement
Class III
·Terminated·Helix Medical LLC·November 13, 2013