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    EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

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

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

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

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033225·Baltic Denture System BDLoad BDLoad ↓ Mw6 PLSEu...

    Reprocessed Oscillating Sagittal Saw Blade, 31 x 9mm

    FDA UDI
    SURETEK MEDICAL·B390KM332251·

    Brasseler USA

    FDA UDI
    Provision·00810041064943·

    Brasseler USA

    FDA UDI
    Provision·B504OMKM332250·

    NA

    FDA UDI
    STERILMED, INC.·10888551017114·SAW BLADE MICRO OSCILLATING 9 TEETH/CM STRYKER ...

    NA

    FDA UDI
    STRYKER CORPORATION·04546540047014·Precision (9.0 x 0.51 x 31.0mm)

    INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·December 10, 2018

    MATRIX THREADED PERSUADER- STANDARD

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·April 3, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 30, 2011

    XXL BALLOON DILATATION CATHETER

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC·Product code LOX·April 11, 2008

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024