BEUDAMED
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    5.0 MHZ INTRACAVITARY SECTOR PROBE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Legacy™3 Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307102069·Ø3.7 x 11.5 Platform 3.5mmD

    Stainless Steel Wire

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746047763·WIRE SS UPPER 019 X 025 BONWILL HAWLEY 10/PK

    INHALATION THERAPY NEBULIZER DEVICE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    THERMO SENTRY 1200 THERMO-SYS-TS1200

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DENTAL IMPLANT

    FDA Adverse Event
    Malfunction ·BIOMET 3I, LLC·Product code NDP·May 30, 2023

    DENTAL IMPLANT

    FDA Adverse Event
    Malfunction ·BIOMET 3I, LLC·Product code NDP·May 30, 2023

    DENTAL IMPLANT

    FDA Adverse Event
    Malfunction ·BIOMET 3I, LLC·Product code NDP·May 30, 2023

    DENTAL IMPLANT

    FDA Adverse Event
    Malfunction ·IMPLANT DIRECT SYBRON MANUFACTURING LLC·Product code DZE·May 30, 2023

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 6, 2014

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    GENTEEL HOMECARE PRODUCTS·Product code ITJ·December 3, 2012

    REPAIR CORE RECIP SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·August 30, 2010

    5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135; 14" (36 cm) Appx 4.8 ml, Bifuse Add-On Set w/Spiros w/Red Cap, Bag Spike, 3 Clamps (Blue, 2 White), Vented Cap, Drop-In Spiros w/Red Cap, REF: CH3156; 114" Bifuse Primary Set w/2 Spiros, Bag Spike, 2 20 Drop In-line Drip Chamber, Clave, Bag Hanger, REF: CH3240; 18 IN (46 cm) Appx 2.9 ml, Add-On Set w/Spiros, Clave Spike, Clamp, Cap, REF: CH3290; 27" (69 cm) Appx 5.2 ml, Bifuse Add-On Set w/15 Drop Drip Chamber, Spiros w/Red Cap, Check Valve, Vented Cap, Bag Hanger, REF: CH3294; Secondary IV Oncology Kit, REF: CH3322; 30 IN (76 cm) Appx 1.8 ml) Ext Set w/2 Spiros, 2 Red Caps, Clamp, REF: CH3327; 40" (102 cm) Appx 4.6 ml, Admin Set, 2 Spiros w/2 Red Caps, 20 Drop In-Line Drip Chamber, 2 Bag Hangers, REF: CH3373; Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port, REF: CH3397; 45" (114 cm) Appx 5.8 ml, Ext Set w/MicroClave, 2 Clave, Spiros w/Red Cap, 2 Clamps, REF: CH3403; Oncology Kit w/20" (51 cm) Ext Set w/MicroClave, Graduated Connector, Transfer Set w/Clave Additive Port, Spiros, Red Cap, 13mm Vial Spike w/Clave, REF: CH3507; Oncology Kit w/Clave Universal Vented Vial Spike, Spinning Spiros w/Red Cap, REF: CH3546; 22" (56 cm) Add-On 150 ml Burette Set (MicroClave, No Shut-Off), w/Spiros, 2 Clamps, Vented Cap, REF: CH3554; 4.5 IN (11 cm) Appx 0.43 ml, Ext Set, Spiros w/Red Cap, REF: CH3559; Oncology Kit w/Spinning Spiros, C-Clip, Red Cap, REF: CH3581; 5 IN (13 cm) Appx 0.57 ml, Ext Set, Anti-Siphon Valve, Spiros, REF: CH3582; Oncology Kit w/Spinning Spiros w/Red Cap, C-Clip; Priming Cap, REF: CH3589; 77" (196 cm) Appx. 9.4 ml, Admin Set w/2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber, Bag Hanger, REF: CH3639; 22" (56 cm) Appx 5.6ml, Ext Set, Trifuse w/4 Clave Clear, Spiros w/Red Cap, 1.2 Micron Filter, 4 Clamps, REF: CH3770; 6.5 IN (17 cm) Appx 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros, Red Cap, REF: CH3771; 47" (119 cm) 50 ml Diluent Set for Channel 2 w/20 Drop In-Line Drip Chamber, 2 Spiros, REF: CH4001; 47" (119 cm) 50 ml Diluent Set For Channel 2 w/Bag Spike w/MicroClave Additive Port, Spiros, REF: CH4009; 30" (76 cm) Appx 5.9 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Filter, Spiros, Hanger, REF: Z7100; 30" (76 cm) 50 ml Diluent Set for Channel 2 w/Spiros, REF: CH4006; 60 IN(152cm)APPX 0.45ml,SMALLBORE EXT,MicroCLAVE,Spiros, REF: Z7040; 6" (15 cm) Appx 0.55 ml, Smallbore Trifuse Ext Set w/3 MicroClave, 3 Clamps, Spiros, REF: Z7151

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 30, 2020

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025