BEUDAMED
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    QUADRA CATH ELECT(3MM SIZES) 1990J, JF, JP + JPF

    FDA 510(k)
    FDA Class 2 ·Neurology

    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code CBK·August 11, 2016

    H-WAVE E STIMULATOR

    FDA Adverse Event
    Injury ·ELECTRONIC WAVE FORM, LAB INC.·Product code JPF·November 21, 2000

    BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTM·April 20, 2012

    BIODESIGN SURGISIS ANTERIOR PELVIC FLOOR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTM·January 14, 2013

    BIODESIGN 4-LAYER TISSUE GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTM·February 26, 2014

    Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA DisFor use with Light Cycler 2.0 instrument; The Factor II (Prothrombin) G20210A Kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor II DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor II DNA. The Factor II (Prothrombin) G20210A test is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 Instrument using the Roche Confidential Page 3 of 9 LightCycler Software 4.05 or 4.1. The specimen preparation must be performed according to the workflow procedures described in the package insert.tributed by Roche Diagnostics Indianapolis, IN 46256 USA; 03610195001

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JPF·March 31, 2011

    Prothrombin-Proconvertin And Thrombotest

    FDA classification
    FDA Class 2 ·Prothrombin-Proconvertin And Thrombotest

    HPF S.R.L.

    FDA registration
    HPF S.R.L.·27 products·🇮🇹 Italy

    JPI Healthcare Co., Ltd

    FDA registration
    JPI Healthcare Co., Ltd·4 products·🇰🇷 South Korea

    RX APF (CASTING ALLOY)

    FDA 510(k)
    FDA Class 2 ·Dental

    SHANGHAI JPY ION-TECH CO., LTD.

    FDA registration
    SHANGHAI JPY ION-TECH CO., LTD.·68 products·🇨🇳 China

    SHENZHEN JPY ION-TECH. CO., LTD.

    FDA registration
    SHENZHEN JPY ION-TECH. CO., LTD.·20 products·🇨🇳 China

    TIANJIN JPY ION-TECH. CO., LTD.

    FDA registration
    TIANJIN JPY ION-TECH. CO., LTD.·2 products·🇨🇳 China

    APF POROUS COATED LINE EXTENSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POROUS APF/MODULAR FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Xiamen JPL Industry & Trade Co. Ltd.

    FDA registration
    Xiamen JPL Industry & Trade Co. Ltd.·2 products·🇨🇳 China

    POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Aurofluid 2 PF

    FDA UDI
    Cendres+Métaux SA·97640173080100·Aurofluid 2 PF

    ADAPTER HC/HPF

    FDA UDI
    HPF SRL·08057968711525·