BEUDAMED
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    Olympus DISPOSABLE GRASPING FORCEPS, FG-51D

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 1, 2022

    ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·October 9, 2019

    01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·May 3, 2017

    Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument.

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·August 19, 2020

    Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument.

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·August 19, 2020

    ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·October 9, 2019

    AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia.

    FDA Enforcement
    Class II ·Terminated·Advandx Inc·October 31, 2012

    CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.

    FDA Enforcement
    Class II ·Terminated·INNOKAS MEDICAL OY·August 31, 2016

    VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.

    FDA Enforcement
    Class II ·Terminated·INNOKAS MEDICAL OY·February 4, 2015

    CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

    FDA Enforcement
    Class II ·Terminated·Innokas Medical Oy·November 18, 2015

    Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    FDA Enforcement
    Class II ·Terminated·Palodex Group Oy·January 29, 2020

    KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    FDA Enforcement
    Class II ·Terminated·Palodex Group Oy·January 29, 2020

    Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    FDA Enforcement
    Class II ·Terminated·Palodex Group Oy·January 29, 2020

    Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

    FDA Enforcement
    Class II ·Terminated·Palodex Group Oy·January 29, 2020

    The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm. FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

    FDA Enforcement
    Class II ·Terminated·Instrumentarium Dental, PaloDEx Group Oy·March 5, 2014

    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212

    FDA Enforcement
    Class III ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·September 12, 2018

    NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)06438147295708(17)180630(10)654923 (01)06438147295708(17)180630(10)655680 (01)06438147295708(17)180630(10)655300 (01)06438147295708(17)180630(10)654924 (01)06438147295708(17)180831(10)656025 (01)06438147295708(17)180831(10)657055 (01)06438147295708(17)180831(10)656170 (01)06438147295708(17)180831(10)656320 (01)06438147295708(17)181031(10)657768 (01)06438147295708(17)181031(10)657513 (01)06438147295708(17)181031(10)658006

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·May 16, 2018

    Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·February 8, 2017

    Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·April 19, 2017

    Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·February 8, 2017