BEUDAMED
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    IBD-QUIK CHEK

    FDA 510(k)
    FDA Class 1 ·Immunology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5820307040·SCISSORS, SURGICAL TISSUE, DENTAL

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065692·INTRAORAL ELASTICS 4,5 oz 3/16" green

    Single Use Biliary Stent V

    FDA UDI
    OLYMPUS MEDICAL SYSTEMS CORP.·04953170186356·Single Use Biliary Stent V

    SINGLE USE BILIARY STENT V

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FGE·May 21, 2022

    SANARUS CENTRICA ROTATIONAL CORE BIOPSY SYSTEM

    FDA Adverse Event
    Malfunction ·SANARUS MEDICAL·Product code KNW·September 3, 2003

    DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)

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

    OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.

    FDA Enforcement
    Class III ·Terminated·Advanced Sterilization Products·December 11, 2013

    COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code FMT·March 5, 2010

    PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code FGE·January 4, 2021

    5.5MM TI CURVED ROD 40MM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·April 2, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·March 22, 2011

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·April 15, 2008

    EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 21 Fr. Product code ER21 (07043). The cannulas are also packaged in kits that have no specific lot number. The EndoReturn arterial cannula is packaged in the ''EndoCPB (Cardiopulmonary Bypass) System with Cardioplegia Catheter, Product codes ECPB211, 212, 213, 214, 231, 232. Also, the EndoCPB system without Cardioplegia Catheter, Product codes ECPB211, 212, 231, 232.

    FDA Recall
    Terminated ·Heartport Inc Route·Product code DWF·October 2, 2003

    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