23 results
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21ms
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Sources: EU EUDAMED, US FDA
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