BEUDAMED
    16 results · 17ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ERECTAID

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

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517138491·Helix R Screw, 4x11mm Var Self-Tap

    N/A

    FDA UDI
    inomed Medizintechnik GmbH·04250307606108·Headring, aluminium

    Gen. Scissors

    FDA UDI
    KATENA PRODUCTS, INC.·00841668118412·Westcott Tenotomy Sciss., RT, Wide Hdl

    PC

    FDA UDI
    Allied Medical, LLC·00026072016053·FTG,AIR,ML DS X 1/8" ML W/CK

    STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES

    FDA 510(k)
    FDA Class 2 ·Neurology

    IMPELLA 5.0 CATHETER FAMILY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2014

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 19, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 31, 2007

    Product is 40mm Flexible Tube. ***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DRIVE , REPLY TO POST OFFICE BOX 18009, JACKSONVILLE, FLORIDA 32229-8009 USA, 1-800-874-7711. Part # 80-3111-01 Lot 052190 QTY 76 Pieces 10/18/2005. Sold for use with: Part # 80-3111-01 Lot 052190 Qty 14. Part # SP-1651 Lot # 069330 Qty 10. Part # SP-1639 Lot # 046230 Qty 4. Part # SP-1598-13 Lot # 041960 Qty 10. Part # SP-1329 Lot # 039700 Qty 10. Part # SP-1331 Lot # 039720 Qty 12. Part # SP-1330 Lot # 039710 Qty 11. Part # SP-1633 Lot # 056630 Qty 5. Product Usage: Distraction devices are for use in bone stabilization and elongation (lengthening) when correction of oral, cranial, mandibular and maxiollofacial deficiencies or post traumatic defects require gradual bone distraction. Each implantable distraction device has a titanium alloy drive screw mechanism and LactoSorb resorbable correction plates, which are implanted by fixation with LactoSorb bone screws.

    FDA Recall
    Terminated ·Walter Lorenz Surgical, Inc.·Product code JEY·February 17, 2006

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021