BEUDAMED
    21 results · 35ms · Sources: EU EUDAMED, US FDA

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    CODMAN ISOCOOL BIPOLAR FORCEPS

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

    AIMING ARM/ RADIOLUCENT

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·September 17, 2021

    COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PERFORMANCE TOTAL KNEE PROSTHESIS

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HRY·October 25, 2019

    PERFORMANCE DISTAL FAB LM/RL MED

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016

    PERFORMANCE DISTAL FAB LL/RM MED

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016

    VANGRD CR POR/HA FEM - RT 72.5

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·March 31, 2016

    TINBN VNGRD INT CR ANAT FEMORAL R 62.5 MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·March 31, 2016

    VANGUARD CR POROUS/HA FEM - RT 72.5

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·March 23, 2016

    UNKNOWN DEPUY SZ 5 FB TIB TRAY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JWH·March 27, 2013

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES INC.·Product code MCW·March 16, 2011

    ACRYSOF RESTOR

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD./ HUNTINGTON·Product code MFK·March 26, 2008

    VANGUARD CEMENTLESS POROUS CR FEMORAL LT 65

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·April 20, 2017

    VANGUARD CRUCIATE RETAINING POROUS HA FEMUR - RIGHT 65 MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·May 12, 2017

    AIMING ARM/ RADIOLUCENT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·September 18, 2023

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 5, 2024

    AIMING ARM/ RADIOLUCENT

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDS·August 25, 2022

    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

    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