BEUDAMED
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    INSORB ABSORBABLE STAPLE, MODEL 1020

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INSORB

    FDA Adverse Event
    Other ·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008

    INSORB

    FDA Adverse Event
    Other ·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008

    INSORB

    FDA Adverse Event
    Other ·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008

    MODIFICATION TO ENVOY PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VIRIDIS LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CERENOVUS ENTERPRISE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·February 24, 2025

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 16, 2013

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code GEI·June 13, 2008

    ETHICON ENDO-SURGERY, INC

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC·Product code FTL·April 13, 2011

    PECTUS SYSTEM JANTON 12" TI PECTUS BAR 3.048CM (12") (L) TITANIUM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 2, 2019

    CERENOVUS ENTERPRISE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·November 26, 2024

    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

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026