BEUDAMED
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    VITEK 2 GRAM POSITIVE LINEZOLID

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032766·Baltic Denture System BDLoad Lm6 PLSEbil2DFlA1 ...

    ECKERT & ZIEGLER ISOTOPE PRODUCTS

    FDA registration
    ECKERT & ZIEGLER ISOTOPE PRODUCTS·3 products·🇺🇸 United States

    PORTABLE INTENSIVE CARE UNIT

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    NICOLET VASOGUARD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COAPTITE INJECTABLE IMPLANT

    FDA Adverse Event
    Injury ·MERZ NORTH AMERICA, INC.·Product code LNM·October 24, 2015

    COAPTITE INJECTABLE IMPLANT

    FDA Adverse Event
    Injury ·MERZ NORTH AMERICA, INC.·Product code LNM·October 25, 2015

    COAPTITE INJECTABLE IMPLANT

    FDA Adverse Event
    Injury ·MERZ NORTH AMERICA, INC.·Product code LNM·October 25, 2015

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·April 3, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 29, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·April 22, 2008

    Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

    FDA Enforcement
    Class II ·Terminated·ArthroCare Medical Corporation·December 17, 2014

    Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes. Brand Name (Catalog Number): ACON Rapid Device Strep A Twist (IST-502T); CONSULT Diagnostics Strep A Twist, PSS (5005); Medi-Lab Performance Strep A Test-Twist, McKesson (32-502T); MooreBrand Strep A Twist Cassette, Moore (82793); and SP Strep A Rapid Twist Cassette Test, Cardinal Health (B1077-29). 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

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024