BEUDAMED
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    Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·June 2, 2021

    BF-MP60: OES Bronchofiberscope

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·May 18, 2022

    OES 4000 Hysteroscope, Model/Catalog Number: A4674A

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·June 12, 2024

    BF-XP60 OES Bronchofiberscope, Model No. BF-XP60

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 6, 2021

    BF-3C40 OES Bronchofiberscope, Model No. BF-3C40

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 6, 2021

    BF-1T60 OES Bronchofiberscope, Model No. BF-1T60

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 6, 2021

    BF-P60 OES Bronchofiberscope, Model No. BF-P60

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 6, 2021

    BF-N20 OES Bronchofiberscope, Model No. BF-N20

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 6, 2021

    Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001

    FDA Enforcement
    Class II ·Ongoing·Dexcom, Inc.·February 26, 2025

    Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.

    FDA Enforcement
    Class II ·Terminated·Dexcom Inc·April 1, 2020

    Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED 22017 B-L - SHUNT 22017 B-L ASSY US PER 90CM SM LOW 22017 B-M - SHUNT 22017 B-M ASSY US PER 90CM SM MED 22017B-LL - SHUNT 22017B-LL ASSY US PER 90CM SM LL 23093 - VALVE 23093 CONT. REG. LOW-LOW 27102 - VALVE 27102 CONTOURED SML LOW LOW 27553 M - VALVE 27553 M CSF-FLOW CNTRL SM EXTR MP 27643M - SHUNT 27643M ASSY SM PCATH130CM MED 27683M - SHUNT 27683M RG SNP PCATH90 PLI STD OE 42312 - VALVE 42312 SM CONTOURED LOW PRES IMP 42314- VALVE 42314 SM CONTOURED MED PRESS IMP 42316 - VALVE 42316 SM CONTOURED HIGH PRESS 42322 - VALVE 42322 CONTOURED REG LOW PRESS IMP 42324 - VALVE 42324 CONTOURED REG MED PRESS IMP 42326 - VALVE 42326 CONT HIGH PRESS IMP 42410 - VALVE 42410 ULTRA SMALL LOW-LOW 42414 - VALVE 42414 ULTRA SMALL MEDIUM PRESS IMP 42532 - VALVE 42532 BURR HOLE 12MM LOW PRESS IMP 42534 - VALVE 42534 BURR HOLE 12MM MED PRESS IMP 42536 - VALVE 42536 BURR HOLE 12MM HI PRESS IMP 42542 - VALVE 42542 BURR HOLE 16 MM LOW IMP 42544 - VALVE 42544 BURR HOLE 16MM MED PRESS IMP 42546 - VALVE 42546 BURR HOLE 16MM HI PRESS IMP 46564 - SHUNT 46564 CSF SNAP ASSY US MEDIUM 46622 - SHUNT 46622 CSF ASSY SMALL LOW CONT C/P 46624 - SHUNT 46624 CSF ASSY SMALL MED CONT C/P 46626 - SHUNT 46626 CSF ASSY SMALL HIGH CONT C/P 46642 - SHUNT 46642 ASSY REG LOW C/P-90CM 46644 - SHUNT 46644 ASSY REG MED C/P-90CM 46646 - SHUNT 46646 ASSY REG HIGH C/P-90CM 9003 A - KIT 9003 A INTL ONLY SHUNT CONT SM LO 9003 B - KIT 9003 B INTL ONLY SHUNT CONT SM ME 9003 C - KIT 9003 C INTL ONLY SHUNT CONT SM HI 9003 D - KIT 9003 D SHUNT INTL ONLY CONT REG L 9003 E - KIT 9003 E SHUNT INTL ONLY CONT REG M 9003 F - KIT 9003 F SHUNT INTL ONLY CONT REG H 9040 A - KIT 9040 A SHUNT INTL ONLY BH 12MM LOW 9040 B - KIT 9040 B SHUNT INTL ONLY BH 12MM MED 9040 C - KIT 9040 C SHUNT INTL ONLY BH 12MM HIGH 9040 D - KIT 9040 DSHUNT INTL ONLY BH 16MM LOW 9040 E - KIT 9040 E SHUNT INTL ONLY BH 16MM MED 9040 F - KIT 9040 A SHUNT INTL ONLY BH 12MM LOW 92322 - VALVE 92322 CSF CONT REG LOW BIO 92324 - VALVE 92324 CSF CONT REG MED BIO

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·February 24, 2021

    Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)

    FDA Enforcement
    Class II ·Ongoing·Withings·March 29, 2023

    SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·January 8, 2014

    The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·September 19, 2012

    Karl Storz, Model # 11161C2, Flexible Neuroscope

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·April 1, 2020

    Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·April 1, 2020

    Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·April 1, 2020

    Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·July 3, 2013

    Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025

    KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

    FDA Enforcement
    Class II ·Ongoing·Pro-Dex Inc·April 26, 2023