BEUDAMED
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    PEAK SUCTION COAGULATOR

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

    RADIANCE

    FDA UDI
    BLV Licht- und Vakuumtechnik GmbH·B5331037750·

    PORTABLE BREAST COMPRESSION DEVICE

    FDA 510(k)
    FDA Class 1 ·Radiology

    TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TAPERLOC COMPLETE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 1, 2025

    BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·February 26, 2023

    UNKNOWN IV CATHETER

    FDA Adverse Event
    Injury ·BD (SUZHOU)·Product code FOZ·January 13, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·September 19, 2014

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code HQL·May 24, 2011

    TAPERLOC COMPLETE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 5, 2025

    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

    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

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    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