BEUDAMED
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    NUVISION™ NAV Ultrasound Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    M/DN®

    FDA UDI
    Zimmer, Inc.·00889024039933·

    DURALOC

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295106821·DURALOC SCREW-IN TRIAL LINER 28mm ID 66mm OD 10...

    NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACON STREP A TWIST TEST DEVICE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ATLAS PLUS HF CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2008

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SAO PAULO·Product code KPE·August 25, 2011

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES·Product code LZG·July 10, 2013

    NEXTAR SPINE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

    G7 HI-WALL ARCOMXL LNR 36MM E

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JDI·February 25, 2019

    BONE SCREW, T8 FULL THREAD, 2.7MM/L14MM

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HWC·February 13, 2023

    LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HWC·February 13, 2023

    BONE SCREW, T8 FULL THREAD, 2.7MM/L20MM

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HWC·February 13, 2023

    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

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026