BEUDAMED
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    TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Signature III

    FDA UDI
    Rmo, Inc.·00885797101679·SIG III ROTH .022, 6 BRKT KIT

    KISTLER MANUS BONE REDUCTION CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896050846·KISTLER MANUS BONE REDUCTION CLAMP

    The Brachiator Mini External Fixation System

    FDA UDI
    Paragon 28, Inc.·00889795151896·Half Pin, Ø3.0 x 100mm OAL x 33mm THD

    Orthoquest

    FDA UDI
    Young Innovations, Inc.·00843471134221·Ss D-Form 016X025

    Mariner Deformity

    FDA UDI
    Seaspine Orthopedics Corporation·10889981297053·Sagittal Bender, Right, 6.0mm

    NA

    FDA UDI
    BICON, LLC·00813110024770·Polishing Kit IAC

    SCAPHIX, STAPLE, FIXATION, BONE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO: HL168W TOUCH SCREEN

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROGAV®

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·January 3, 2018

    TGS UKA SYSTEM

    FDA Adverse Event
    Injury ·CAYENNE MEDICAL, INC·Product code HSX·February 12, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2013

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    GENTEEL HOMECARE PRODUCTS·Product code ITJ·September 19, 2014

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·May 25, 2011

    DISPOSABLE STERILE HIGH TEMPERATURE ELECTROCAUTERY (HTC) F7244

    FDA Adverse Event
    Injury ·FIAB SPA·Product code GEI·October 12, 2023

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    Double foot switch, type KF 2 1S/1 S-MED-AP, manufactured by the company Seute Schaltgerate. GmbH & Co. KG for Ziehm Imaging GmbH Germany, and used with Ziehm Imaging GmbH Mobile C-arm as a component thereof. Two versions were made: 2 pedal version KF 2 1S/1 S-MED-AP foot switch and 4 pedal foot switch version KF 2 1S/1 S-MED-AP This type of foot switch includes a pair of the dual foot switches assembled on a single metal bracket. The following labels may appear on the foot switch: Labeled in part: "Fluoro- Store***ZIN Part no. # 58371***ZIR Part no. # 10-2985*** Left Pedal: Initiate Radiation***Right Pedal: Store Image***" Labeled in part: "Fluoro - Cine***ZIN Part no. # 58415***ZIR Part no. # 10-2987*** Left Pedal: Initiate Radiation***Right Pedal: Switch into Cine mode***" Labeled in part: "Fluoro - Mag***ZIN Part no. # 58413***ZIR Part no. # 10-2989*** Left Pedal: Initiate Radiation***Right Pedal: Switch through magnification***" Labeled in part: "Fluoro -Snap***ZIN Part no. # 58417***ZIR Part no. # 10-2991*** Left Pedal: Initiate Radiation ***Right Pedal: Initiate Snapshot***" Labeled in part: "DSA - CINE***ZIN Part no. # 58419***ZIR Part no. # 10-2993*** Left Pedal: Switch into DSA mode ***Right Pedal: Switch into Cine mode***" Labeled in part: "Cine - Store***ZIN Part no. # 58421***ZIR Part no. # 10-2995*** Left Pedal: Switch into Cine mode***Right Pedal: Store Image***" Labeled in part: "Cine - LONG:Endo ON/OFF & SHORT:Freeze*** ZIN Part no. # 58423***ZIR Part no. # 10-2997*** Left Pedal: Switch into Cine mode***Right Pedal: Long: Switch Endo On/Off Short: Freeze the endoscopic image on live screen***" Labeled in part: "Cine- Endo ON /OFF***ZIN Part no. # 58425***ZIR Part no. # 10-2999*** Left Pedal: Switch into Cine mode***Right Pedal: Switch Endo On / Off***" Labeled in part: "Fluoro - Swap***ZIN Part no. # 58427***ZIR Part no. # 10-3031*** Left Pedal: Initiate Radiation***Right Pedal: Swaps the image between the live and reference screens***" Labeled in part: "DSA / MSA/RSA - OFF***ZIN Part no. #58429***ZIR Part no. #10-3033***Left Pedal: Switch DSA/MSA/RSA On***Right Pedal: Switch DSA/MSA/RSA Off***" The KF 2 1S/1S-MED- AP foot switch is a component of the Mobile C-arm and is used by the physician to activate Fluoroscopic X-Ray for imaging by pressing the foot switch.

    FDA Recall
    Terminated ·Ziehm Imaging Inc·Product code JAA·April 29, 2011

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021