BEUDAMED
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    CellaVision DC-1, CellaVision DC-1 PPA

    FDA 510(k)
    FDA Class 2 ·Hematology

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003500·Diagnostic EP Catheter, Small 60 curve, 10 elec...

    7930 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00817136022352·MED ADULT M/F MASK W/CAP/CLIPS

    24M - The Braun Corp - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588095950·24M - The Braun Corp - Metal

    DEBAKEY COLLIN LUNG FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896092952·DEBAKEY COLLIN LUNG FORCEPS

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694016261·1.2mm/1.6mm Plate Organizer

    Olympus

    FDA UDI
    Gyrus ACMI, LLC·00821925047082·nCare 4K Audio Cables

    iSmile

    FDA UDI
    Ismile Dental Products, Inc.·00816419021457·VP Micro Brush Applicator Regular Orange

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528123232·Upper Tray, Orbital Floot Plate Module

    XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DIMENSION PENTA L

    FDA 510(k)
    FDA Class 2 ·Dental

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011

    TOTAL ASR ACET IMP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 1, 2013

    ROD,FIXATION,INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·April 25, 2016

    ROD,FIXATION,INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·April 25, 2016

    UNKNOWN - NAIL (TITANIUM ENDOMEDULLARY)

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 2, 2016

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021