BEUDAMED
    22 results · 21ms · Sources: EU EUDAMED, US FDA

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    DRG CEMETED STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950025084·HAMMER PERCUSSION 8" 20CM

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89200031·Mand. 1. Molar band W-Fit left 03

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117728·Modular Tibia Tray Trial Size 3

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89200030101·Mand. 1. Molar band W-Fit left 03

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89200030051·Mand. 1. Molar band W-Fit left 03

    Matching Limb Protection Sleeves - Vari-Fit

    FDA UDI
    Delfi Medical Innovations Inc·M995979200031·Delfi Matching Limb Protection Sleeves (MLPS) h...

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89200030501·Mand. 1. Molar band W-Fit left 03

    Matching Limb Protection Sleeves - Vari-Fit

    FDA UDI
    Delfi Medical Innovations Inc·M995607920003001·Delfi Matching Limb Protection Sleeves (MLPS) h...

    ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NUCAL

    FDA 510(k)
    FDA Class 2 ·Dental

    NA

    FDA UDI
    Zimmer, Inc.·00889024076839·

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 24, 2024

    B1005, ACUCISE ENDOPYELOTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017

    11/13 S-ROM 40MM M SPEC+3 (RIGHT)

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 17, 2013

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 3, 2010

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 8, 2014

    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 24, 2013

    Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number): Acceava Strep A Cassette (92004 E-Z); Accutest Integrated Strep A Rapid Test Device JANT (ID440); ACON Strep A Rapid Test Device (IST-502); BD Directigen EZ Group A Strep, Becton Dickinson (256032); Clearview Strep A Exact II Cassette (920003), CONSULT Diagnostics Strep A Cassette, 25T, PSS (5004); CONSULT Diagnostics Strep A Cassette, 50T, PSS (5009); Detector Strep A Direct, Immunostics (IMMIL-Strep25); E-Z Well Strep A Test Device, 25T, StanBio (6100-025L), E-Z Well Strep A Test Device, 5T, StanBio (6100-05L); Henry Schein One Step + Strep A Cassette Test (9004051); Medi-Lab Performance Strep A Test-Cassette, McKesson (32-502); Poly stat Strep A Cassette Test, Polymedco (STC 20); Signify Strep A Cassette (1P47-40); and SP Brand Strep A Rapid Cassette Test, Cardinal Health (B1077-26). Type of Packaging (ie. box, plastic bag): Individually pouched devices (number of tests per kit varies from 5 to 50), the kits also include: disposable extraction test tubes, dropper tips, sterile swabs, 1 vial Strep A reagent A (10 mL): 2M Sodium Nitrite, 1 vial Strep A reagent B (10 mL): 0.4M Acetic Acid, 1 vial Strep A positive control (1 mL): Nonviable Strep A; 0.09% NaN3, 1 vial Strep A negative control (1 mL): Nonviable Strep C; 0.09% NaN3 in a labeled kit box. The Strep A Rapid Test Cassette and Twist devices are qualitative, lateral flow immunoassays for the detection of Strep A carbohydrate antigen in a throat swab, providing results within 5 minutes. The tests utilize antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen. The Cassette device uses a drop-wise application method while the Twist device has an onboard well to extract the throat swab specimen. The Strep A Rapid Test Devices are rapid chromatographic immunoassays for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only.

    FDA Recall
    Terminated ·Alere San Diego·Product code GTY·September 1, 2011

    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