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    EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    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

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00126411·

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00112411·

    ActivHeal

    FDA UDI
    ADVANCED MEDICAL SOLUTIONS LIMITED·15032749001248·SILICONE WOUND CONTACT LAYER 5X7.5CM

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001241·artVeneer life upper anteriors, BIL, B3

    Silicone Tubing

    FDA UDI
    INVOTEC INTERNATIONAL, INC.·00818501023073·Silicone Tubing 0.188" X 0.313"

    RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR

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

    AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD

    FDA 510(k)
    FDA Class 2 ·Dental

    PRISMA CONTROL UNIT

    FDA Adverse Event
    Injury ·GAMBRO DASCO·Product code KDI·March 22, 2006

    PRISMA CONTROL UNIT

    FDA Adverse Event
    Malfunction ·GAMBRO DASCO·Product code KDI·March 22, 2006

    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

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·February 24, 2011

    ASCENSIA BREEZE (US)

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

    GMK-HINGE FIXED TINBN COATED TIBIAL TRAY - 3R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 8, 2023

    HANDLE CEV669B DIA 5MM ANG BIPOLAR

    FDA Adverse Event
    Malfunction ·INTEGRA MICROFRANCE S.A.S.·Product code GEI·October 16, 2019

    INTACS PRESCRIPTION INSERTS

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

    LM-900 N2O CE CRYOSURG SY

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GEH·April 22, 2022