BEUDAMED
    19 results · 31ms · Sources: EU EUDAMED, US FDA

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    Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809844917·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE LARGE ...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197133·Revision Knee Spiral Reamer- Hudson Short Flute...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0131100·Rod Inserter, Fixed, 90 Degree, MIS

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0131100·Assembly, Rod Inserter, Fixed UNID

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0131100·Rocker, One Piece

    MEDCOMP BIO-CATH CATHETER LINE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ANISEIKONIA INSPECTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SYNCHRON® LX20 PRO ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·April 11, 2013

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·May 28, 2008

    2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·February 28, 2023

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211 21-103212 21-103215 21-104109 21-104110 21-104111 21-104112 21-104113 21-104114 21-104115 21-104116 21-104117 21-104118 21-104119 21-108110 21-108112 21-108115 21-108117 21-108119 21-108130 21-108132 21-108135 21-108137 21-108139 21-108150 21-108152 21-108155 21-108157 21-108159 21-108251 21-108253 21-108255 21-108257 21-108259 21-108271 21-108273 21-108275 21-108277 21-108279 21-108291 21-108293 21-108295 21-108297 21-108299 21-108391 21-108393 21-108395 21-108397 21-108399 21-109256 21-109260 21-109264 21-109268 21-109272 21-123202 21-123203 21-123204 21-123205 21-123206 21-123207 21-123208 21-123209 21-123210 21-123211 21-123212 21-124309 21-124310 21-124311 21-124312 21-124313 21-124314 21-124315 21-124316 21-124317 US157338 US157340 US157342 US157344 US157346 US157348 US157350 US157352 US157354 US157356 US157358 US157359 US157360 X21-180307 X21-180308 X21-180309 X21-180310 X21-180311 X21-180312 X21-180313 X21-180314 X21-180315 X21-180316 X21-180317 X21-180318 X21-180319 X21-180320 X21-180321 X21-182308 X21-182309 X21-182310 X21-182311 X21-182312 X21-182313 X21-182314 X21-182315 X21-182316 X21-182317 X21-182318 X21-182319 X21-182320 X21-182321 Product Usage: Hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019