5,567 results
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Sources: EU EUDAMED, US FDA
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The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films.
FDA Recall
Open, Classified
·Carestream Health, Inc.·Product code IZL·October 2, 2023
CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA1815SB/CNB, CORCA1820SB/CNB, CORCA2015SB/CNB, CORCA2020SB/CNB
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code KNW·August 3, 2022
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110SN/D, 28MC24110ST/D, 28MC2413045/D, 28MC24130SN/F, 28MC24130ST/D, 28MC24130ST-W/A, 28MC2415045/D, 28MC24150ST/D, 28MC24150ST/F, 28MC28110ST/D, 28MC2813045/D, 28MC28130SN/D, 28MC28130SN/F, 28MC28130ST/D, 28MC28150SN/D, 28MC28150SN/F, 29MC2911045/D, 29MC29130SN/F, 29MC29130ST/D, 29MC29150ST/CNB, 29MC29150ST/D, CE 2797, STERILEEO, Rx ONLY
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code KRA·November 6, 2023
PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code DTL·August 4, 2025
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
FDA Recall
Open, Classified
·Zimmer, Inc.·Product code PHX·May 20, 2026
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
FDA Recall
Open, Classified
·Zimmer, Inc.·Product code PHX·May 20, 2026
MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
FDA Recall
Open, Classified
·Medtronic Inc.·Product code N/A·April 30, 2020
Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830
FDA Recall
Open, Classified
·Rebiscan, Inc.·Product code PMW·October 3, 2022
VIDAS Lyme IgG II (LYM), REF 417401
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code LSR·September 22, 2021
VIDAS RUB IgG (RBG), REF 30226
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code LFX·September 22, 2021
VIDAS Lyme IgM II (LYM), REF 416436
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code LSR·September 22, 2021
VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
FDA Recall
Open, Classified
·Biomerieux Inc·Product code LON·November 9, 2022
VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217
FDA Recall
Open, Classified
·Biomerieux Inc·Product code LFY·November 9, 2022
ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JTO·November 9, 2022
ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022
PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JSO·November 9, 2022
PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JSI·November 9, 2022
ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331
FDA Recall
Open, Classified
·Biomerieux Inc·Product code JWY·November 9, 2022