BEUDAMED
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    FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM

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

    Bur PM2-70 50K Carb Xcut Ø5.0

    FDA UDI
    Bien-Air Surgery SA·07630055503978·

    Digital Analogue MINI

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059074710·

    IN-OVATION® Czr

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807H100442101·IN-OVATION® CZR Base Rx .022 LL4 -17T -1A 4A HK

    IN-OVATION® Czr

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807H100442001·IN-OVATION® CZR Base Rx .022 LL4 -17T -1A 4A

    NA

    FDA UDI
    Zimmer, Inc.·00889024460058·

    KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·January 5, 2023

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 8, 2013

    HMS PLUS INSTRUMENT

    FDA Adverse Event
    Injury ·PERFUSION SYSTEMS·Product code JOX·September 19, 2014

    NC SPRINTER RX BALLOON DILATATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code LOX·May 17, 2011

    PRESIDIO 18 CERE 9MMX33CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·March 9, 2021

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-03220AP K10-05251AP K10-04479P K10-01722QP K10-04931B K10-04429 K10-06012P K10-05043A K10-06066 K10-06011AP K10-06033AP K10-06086P K10-05222 K10T-00856B K10T-01343F K10T-03849G K10T-05668D K10T-05403 K10T-03958L K10T-05139 K10-05343 K10T-04662A K10-04800DP K10T-05428 K10T-04278C K10T-04942A K10T-04216G K10T-04110B K10-04201GP K10-01571C K10T-05261 K10-04183CP K10-00839FP K10-00785LP K10-00777BP K10-04413A K10-00592K K10-05097A K10-05774P K10-05636A K10-03327D K10-00814L K10-04360B K10-03383BP K10-01270T K10-04621 K10-05913P K10-05472 K10-04693D K10-03290D K10T-04335A K10-04426B K10-01700AP K12-05018 K10-05274AP K10-05511 K10T-04155C K10T-03903F K10T-04978H K10T-03997F K10-03364A K10-05833P K10-05097B K10-05700 K10-03184 K10-05457AP K10-05675 K10-03666B To support the withdrawal and collection of fluids from the body.

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code PPD·June 11, 2024

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P K10-03220AP K10-05251AP K10-04479P K10-01722QP K10-04931B K10-04429 K10-06012P K10-05043A K10-06066 K10-06011AP K10-06033AP K10-06086P K10-05222 K10T-00856B K10T-01343F K10T-03849G K10T-05668D K10T-05403 K10T-03958L K10T-05139 K10-05343 K10T-04662A K10-04800DP K10T-05428 K10T-04278C K10T-04942A K10T-04216G K10T-04110B K10-04201GP K10-01571C K10T-05261 K10-04183CP K10-00839FP K10-00785LP K10-00777BP K10-04413A K10-00592K K10-05097A K10-05774P K10-05636A K10-03327D K10-00814L K10-04360B K10-03383BP K10-01270T K10-04621 K10-05913P K10-05472 K10-04693D K10-03290D K10T-04335A K10-04426B K10-01700AP K12-05018 K10-05274AP K10-05511 K10T-04155C K10T-03903F K10T-04978H K10T-03997F K10-03364A K10-05833P K10-05097B K10-05700 K10-03184 K10-05457AP K10-05675 K10-03666B To support the withdrawal and collection of fluids from the body.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025