BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

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    HGM ILLUMINATING IMAGING ENDOCULAR PROBE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010

    TRANSEND EX 14 GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION·Product code DQX·September 23, 2009

    RANGE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACON STREP A RAPID TEST DEVICE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code DQX·October 27, 2009

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 2010

    CADD EXT SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·September 29, 2020

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·December 8, 2010

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·January 28, 2013

    DRILL BIT 1.0 MM, LENGTH 46/34MM

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HTW·July 14, 2014

    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