BEUDAMED
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    LAPAROSCOPIC DISSECTOR

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

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517635648·CoRoent Ant TLIF PEEK, 10x13x28mm 12°

    Bernafon

    FDA UDI
    Bernafon AG·05711584003442·MD3 CPx, VC PS BE MONDO 3

    HAND SURGERY OSTEOTOME

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896052550·HAND SURGERY OSTEOTOME STRAIGHT BLADE

    GORE INTRODUCER SHEATH

    FDA 510(k)
    FDA Class 1 ·Immunology

    FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·September 16, 2016

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 9, 2013

    POSITIONER, SHOULDER EXPOSURE T-MAXII

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code FWZ·September 19, 2014

    MULTIFIRE SCORPION NEEDLE

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HRX·May 26, 2011

    ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·December 29, 2015

    SURSHIELD PUR SAFETY I.V. CATHETER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015