52 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
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-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
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
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·April 29, 2026
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·November 29, 2023
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
FDA Enforcement
Class II
·Ongoing·Turbett Surgical, Inc.·February 8, 2023
Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
FDA Enforcement
Class II
·Ongoing·Turbett Surgical, Inc.·February 8, 2023
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·November 29, 2023
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103
FDA Enforcement
Class II
·Ongoing·Scican Ltd.·August 9, 2023
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 622303
FDA Enforcement
Class II
·Ongoing·Scican Ltd.·August 9, 2023
The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FMHT77506. These products were produced for DeWALT and Stanley by a contract manufacturer.
FDA Enforcement
Class II
·Ongoing·STANLEY BLACK & DECKER INC.·January 8, 2020
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process.
FDA Enforcement
Class II
·Ongoing·Young Dental Mfg Co I LLC·February 9, 2022