31 results
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7ms
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Sources: EU EUDAMED, US FDA
VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL CT VIO 8X18IN 0 S/A CT-1 CR VICRYL SUTURE 18"(45CM) 1 VIO VCL CT UD 8X18IN 2-0 S/A CP-2 CR VCL CT VIO 8X18IN 3-0 S/A SH-1 CR VICRYL CT VIO 8X18IN 2-0 S/A SH CR VICRYL CT UD 8X18IN 2-0 S/A CT-1 CR VICRYL CT UD 8X18IN 0 S/A CT-1 CR VCL CT UD 8X18IN 1 S/A CT-1 CR 9 VICRYL SUTURE 18"(45CM) 0 UND VICRYL CT VIO 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 1 UND VICRYL CT UD 8X27IN 0 S/A CT-1 CR VICRYL SUTURE 27"(70CM) 0 VIO
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·April 24, 2019
PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·July 25, 2018
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
FDA Enforcement
Class II
·Terminated·SA3, LLC·April 13, 2022
Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·April 25, 2018
SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
FDA Enforcement
Class II
·Terminated·Sam Medical Products·November 5, 2014
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
FDA Enforcement
Class II
·Terminated·Sam Medical Products·March 23, 2022
ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually pouched test devices & collectors in a labeled kit box. The OrALert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugates for binding sites on their specific antibody.
FDA Enforcement
Class II
·Terminated·Alere San Diego, Inc.·January 15, 2014
The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.
FDA Enforcement
Class II
·Terminated·Alere San Diego, Inc.·May 1, 2013
Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.
FDA Enforcement
Class II
·Terminated·Alere San Diego, Inc.·July 25, 2012