BEUDAMED
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    DEPUY ATTUNE KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bur PM2-70 80K diam EC Ø3.5x80 St

    FDA UDI
    Bien-Air Surgery SA·17630055519464·

    Oticon

    FDA UDI
    Oticon A/S·05707131164353·K13, RITE SGR

    NITANIUM® SUPER ELASTIC ARCHWIRES

    FDA UDI
    Ortho Organizers, Inc.·00190707060121·.014 LOWER NITANIUM® SUPER ELASTIC OVAL ARCH FO...

    Orthoquest

    FDA UDI
    Young Innovations, Inc.·00843471156193·V D-Form 016X025

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383501095·Gutta Percha Points is used to root canal filin...

    Young Specialties

    FDA UDI
    Young Innovations, Inc.·00840326425954·NiTi SE Archwire, D-FORM .016x.025 10EA

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971307·

    CNS-9300 SERIES CENTRAL STATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BALLERT CRANIAL MOLDING HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 5MG/4MG

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·April 1, 2026

    DEVICE 0127/101433 IMPLANTED 13-JUN-2001

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code KRG·May 7, 2010

    X SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 29, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 25, 2011

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 5, 2026

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012