BEUDAMED
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    FIBRINOGEN SCREEN

    FDA 510(k)
    FDA Class 2 ·Hematology

    Polishers

    FDA UDI
    DFS - DIAMON GmbH·04057176151995·2comp pol. cup CA 6pcs

    HEART STABILIZER FINGER ATTACHMENT

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09928008260·HEARTLINE HEART STABILIZER FINGER ATTACHMENT 2L...

    HEART STABILIZER FINGER ATTACHMENT

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896070295·HEARTLINE HEART STABILIZER FINGER ATTACHMENT 2L...

    ACUMED

    FDA UDI
    Acumed LLC·10806378045097·2.3mm Long Screw Caddy Lid

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450178799·

    ADP,8,P800,(2)S800,1/4",N,INTERCALL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828118712·ADP,8,P800,(2)S800,1/4",N,INTERCALL

    PRODIGY LATERAL VIEW SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    PENUMBRA CATHERER 025

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SILHOUETTE INFUSION SET

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FPA·April 22, 2003

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 8, 2014

    HIRES 90K

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·October 17, 2012

    PFC SIGMARP CV TB/IN S3 12.5

    FDA Adverse Event
    Injury ·DEPUY-CORK/DIV OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·August 10, 2010

    IMS Patient Scale used on Sunrise Medical's Hoyer Presence and Stature Patient Lifts (Cradle), Models: HOY-4pt-WSC and HOY-StatureWSC

    FDA Recall
    Terminated ·Integrated Measurement Systems, Inc.·Product code FRW·January 30, 2007

    Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device intended for medical purposes. The bed includes a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed.

    FDA Recall
    Terminated ·Joerns Healthcare·Product code FNL·September 24, 2014

    SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen.

    FDA Recall
    Terminated ·Sequal Technologies Inc·Product code CAW·October 1, 2009

    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022