BEUDAMED
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    TRUEBEAM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481118265·LOCATOR R-Tx Abutment For 3.8mm Premium, Sweden...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450159491·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311111060·

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321111060·

    TALOS®-T

    FDA UDI
    SpineArt SA·07640332471579·TALOS-T (HA) LORDOTIC HA PEEK IBFD 6° L28 W10...

    SYRINGE 3ML LL W/NDL 21X1 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 21, 2020

    STONELITH, MODEL V5

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE

    FDA Adverse Event
    Death ·VOLCANO CORPORATION·Product code DQX·May 9, 2013

    ASPHERE M SPEC 12/14 36 +5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·September 23, 2014

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code MIH·May 25, 2011

    TI SPIRAL BLADE 65MM FOR TI RETROGRADE FEMORAL NAILS-EX

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·April 12, 2018

    5.5 EXP VERSE UNITIZED SET SCR

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

    5.5 EXP VERSE SCR 6.0X45

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

    Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535150; catalog number 3515.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LQR·May 19, 2006

    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024