BEUDAMED
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    SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SORIN C5 SYSTEM WITH MAST ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DWB·May 21, 2012

    FEEDING/DOSING CANNULA

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896053502·FEEDING/DOSING CANNULA STRAIGHT BALL TIP

    Overdenture Abutment

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307114864·

    Multi-Unit Abutment

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307126980·

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 14, 2022

    RIGID GAS PERMEABLE CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ALI 3D TOOL MODULE FOR MEDICAL IMAGES

    FDA 510(k)
    FDA Class 2 ·Radiology

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·January 14, 2019

    CORAIL2 NON COL HO SIZE 10

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS - 3003895575·Product code KWA·September 25, 2015

    OT PING METER

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

    SOLOCARE AQUA

    FDA Adverse Event
    Injury ·CIBA VISION CANADA, INC.·Product code LPN·May 24, 2011

    Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·June 14, 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

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015

    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

    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

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 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