BEUDAMED
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    DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Saw Blade

    FDA UDI
    Gebr. Brasseler GmbH & Co. KG·14053613214817·STRYKER® RECIPROCATOR BLADE REPLACEMENT

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014603902·AMSCO STANDARD-3080/3085 2"POLYFOAM W/LECTROLIT...

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110887·LOCATOR R-Tx Abutment for 3.3mm Camlog Connecti...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481114519·LOCATOR F-Tx Abutment for 3.3mm CAMLOG Connecti...

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094282603·Cuff, Ambulo ABPM, Child 12-19 cm range

    ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS

    FDA Adverse Event
    Injury ·MENICON CO., LTD.·Product code LPL·March 18, 2026

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS

    MENICON ASRB (ASMOFILCONA)

    FDA Adverse Event
    Injury ·MENICON CO., LTD.·Product code LPL·February 25, 2025

    MENICON ASRB (ASMOFILCONA)

    FDA Adverse Event
    Injury ·MENICON CO., LTD.·Product code LPL·January 14, 2025

    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 26, 2013

    VAMP PX KIT JR COMBO PEDIATRIC

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·May 6, 2011

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE, 5 MM DIAMETER - 100 MM LEN

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GCJ·July 17, 2008

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231, IPure™ Preloaded IOL System / Model B1PC (Clear

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·BIOLOGICAL INDICATOR (BI)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·HOYA ISPHERIC INTRAOCULAR LENS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Hoya iSert, Clarisert Intraocular Lens