23 results · 21ms · Sources: EU EUDAMED, US FDA

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Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757

FDA Recall
Open, Classified ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code DFC·December 20, 2024

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

FDA Recall
Open, Classified ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code DFC·December 20, 2024

ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D

FDA Recall
Open, Classified ·Welch Allyn Inc Mortara·Product code DPS·September 3, 2021

Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code GEX·December 4, 2023

CombiDiagnost R90; Model Number: 709031;

FDA Recall
Open, Classified ·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·October 1, 2025

DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;

FDA Recall
Open, Classified ·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code KPR·October 1, 2025

Radiography 7300 C; Model Number: 712037;

FDA Recall
Open, Classified ·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code KPR·October 1, 2025

ProxiDiagnost N90; Model Number: 706110;

FDA Recall
Open, Classified ·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·October 1, 2025

DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;

FDA Recall
Open, Classified ·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·October 1, 2025

Precision CRF; Model Number: 706400;

FDA Recall
Open, Classified ·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·October 1, 2025

One Step P in vitro diagnostic test REF: 8194

FDA Recall
Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code JIR·April 2, 2026

ProxiDiagnost N90. radiography and fluoroscopy system

FDA Recall
Open, Classified ·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code JAA·May 19, 2021

One Step pH in vitro diagnostic test REF: 31I4P

FDA Recall
Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code CEN·April 2, 2026

CombiDiagnost R90 Software Version R1.0 and R1.1

FDA Recall
Open, Classified ·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code JAA·July 22, 2020

DigitalDiagnost 4 High Performance. radiography and fluoroscopy system

FDA Recall
Open, Classified ·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code KPR·May 19, 2021

QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

FDA Recall
Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code CHH·April 2, 2026

Uric Acid in vitro diagnostic test REF: 31H0P

FDA Recall
Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code KNK·April 2, 2026

DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system

FDA Recall
Open, Classified ·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code KPR·May 19, 2021

One Step UTI in vitro diagnostic test REF: 3374

FDA Recall
Open, Classified ·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code LJX·April 2, 2026

DigitalDiagnost C90 High Performance. radiography and fluoroscopy system

FDA Recall
Open, Classified ·Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24-26 Hamburg Germany·Product code KPR·May 19, 2021