BEUDAMED
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    ISA CO2, ISA AX+, ISA OR+

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oticon

    FDA UDI
    Oticon A/S·05707131166135·SAF300SP, BTE DBL DEMO SAFARI 300 SP

    OLSEN-WEBSTER NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896083158·OLSEN-WEBSTER NEEDLE HOLDER DELICATE TUNGSTEN C...

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434557·Tasso+ convenience kit allows self-collection o...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383561723·Gutta Percha Points is used to root canal filin...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383503068·Gutta Percha Points is used to root canal filin...

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964104909·Endo Carry-On Procedure Kit

    Ultraview SL®

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522120213·KIT,DUAL ANT,W/OPS,PLEN ADC,614,W/2AMP

    MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ADAPTERS WITH X-COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·March 3, 2021

    COBAS E411 RACK SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 16, 2008

    PHILIPS CPAP DEVICE

    FDA Adverse Event
    Death ·RESPIRONICS, INC.·Product code BZD·January 2, 2023

    SYNGO SUITE FOR ONCOLOGY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code PAH·May 9, 2013

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code FRN·September 19, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 26, 2011

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA.

    FDA Recall
    Terminated ·Advance Medical Designs Inc·Product code JAA·June 18, 2004

    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