472 results
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9ms
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Sources: EU EUDAMED, US FDA
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20
FDA Enforcement
Class II
·Ongoing·Biocare Medical, LLC·November 13, 2024
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No
FDA Enforcement
Class II
·Ongoing·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·June 18, 2025
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 Enforcement
Class II
·Ongoing·Welch Allyn Inc Mortara·October 13, 2021
(1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow¿ STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-18080-N (4) Arrow¿ STIM CPNB TUOHY NDL: 17G x 8CM (3-1/8") AB-17080-N (5) Arrow¿ STIM CPNB TUOHY NDL: 17G x 14CM (5-1/2") AB-17140-N (6) Arrow¿ INSL CPNB TUOHY NDL: 17G x 15CM (6") AB-00150 (7) Arrow¿ STIM CPNB TUOHY NDL: 17G x 11CM (4-3/8") AB-17110-N
FDA Enforcement
Class II
·Terminated·Arrow International Inc·February 26, 2020
Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)
FDA Enforcement
Class II
·Completed·Basic Reset Inc.·November 20, 2019
Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025
Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
FDA Enforcement
Class II
·Ongoing·DAYE (ANNE'S DAY LTD)·November 5, 2025