211 results
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15ms
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Sources: EU EUDAMED, US FDA
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 21, 2021
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 21, 2021
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
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
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY PACK, Pack Number DYNJ0618509F ; 6) EP DRAPE PACK-LF, Pack Number DYNJ22911I ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ36314J ; 8) SPLIT DRAPE , Pack Number DYNJ37265F ; 9) 4 DRAPE PROCEDURE PACK, Pack Number DYNJ39689D ; 10) DR MOTT DRAPE PACK, Pack Number DYNJ42065B ; 11) PK, EP LAB, Pack Number DYNJ43815C ; 12) MAYO STAND PACK , Pack Number DYNJ50738; 13) DAA BI-LAT, Pack Number DYNJ903538C; 14) PACEMAKER , Pack Number DYNJ903545C; 15) CSTM NEONATAL FEM DRAPE PK, Pack Number DYNJCD0114
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
ORAcollect RNA: ORE-100
FDA Enforcement
Class II
·Ongoing·DNA Genotek Inc.·April 27, 2022
ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
FDA Enforcement
Class II
·Ongoing·DNA Genotek Inc.·April 27, 2022
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.
FDA Enforcement
Class II
·Ongoing·MRP, LLC dba Aquabiliti·February 28, 2024
Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
FDA Enforcement
Class II
·Ongoing·Medical Components, Inc dba MedComp·March 17, 2021