BEUDAMED
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    THE KALIX IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Preat Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092122389·Straumann® TL-compatible RN Engaging Verificati...

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001231·artVeneer life upper anteriors, CL, B3

    Silicone Tubing

    FDA UDI
    INVOTEC INTERNATIONAL, INC.·00818501023066·Silicone Tubing 0.157" X 0.257"

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540350886·SEEKER RIGHT, LH MAXILLARY SINUS

    URANUS, COMFORTOUCH LASER SYSTEM

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

    TRIAGE BNP CALIBRATION VERIFICATION CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    INTACS PRESCRIPTION INSERTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·February 24, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·February 15, 2008

    SYRINGE 20ML LL 120/PKG

    FDA Adverse Event
    Malfunction ·Product code CAZ·May 14, 2020

    INTACS PRESCRIPTION INSERTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006

    127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 13, 2015

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code LMG·May 15, 2023

    INTACS CORNEAL IMPLANTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006

    INTACS PRESCRIPTION INSERTS

    FDA Adverse Event
    Injury ·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006

    98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 13, 2015

    Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FET·September 25, 2023