30 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·October 5, 2022
impression coping, repositionable, short, screw-retained, PF 4.0
FDA Enforcement
Class II
·Ongoing·Thommen Medical AG·March 27, 2024
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GPN:G09767
FDA Enforcement
Class II
·Ongoing·Cook Incorporated·July 3, 2024
HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400
FDA Enforcement
Class II
·Ongoing·Hamilton Co·March 10, 2021
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
FDA Enforcement
Class II
·Ongoing·IHB OPERATIONS B.V.·April 30, 2025
Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.
FDA Enforcement
Class II
·Ongoing·IHB OPERATIONS B.V.·December 13, 2023
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·March 11, 2026
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 14, 2026
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·November 27, 2024
VACUETTE SAFELINK, REF: 450210
FDA Enforcement
Class II
·Ongoing·Greiner Bio-One GmbH·January 15, 2025
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
FDA Enforcement
Class II
·Ongoing·Safeguard US Operating LLC·September 25, 2024
Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set. Convenience kits labeled as follows: Combat Life Saver - Intermediate (Product Number: 83-323-CB) contains 59-300 / 1 Each; Medic Enhancement Resupply (Product Number: 82-504-05) contains 59-300 / 1 Each; Combat Life Saver - Advanced (Product Number: 83-325-CB) contains 59-300 / 1 Each; Cold Weather (Product Number: 82-505) contains 59-300 / 1 Each; HAWK w/ Carrier Set, Multicam, Stocked (Product Number: 83-315-01-MC) contains 59-300 / 1 Each; Mojo Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Mojo Combat Life Saver - Advanced - Multicam (Product Number: 83-325-MC); DIRECT ACTION BAG, FOLIAGE GREEN, ADVANCED, STOCKED (Product Number: 84-497-FG).
FDA Enforcement
Class II
·Ongoing·Safeguard US Operating LLC·September 25, 2024
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·October 2, 2024
HAWK Warming Grid, Item Number: 59-300
FDA Enforcement
Class II
·Ongoing·Safeguard US Operating LLC·September 25, 2024
cobas infinity central lab, Material Number 07154003001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 18, 2023
cobas e801 Immunoassay Analyzer
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·August 17, 2022
IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·June 2, 2021
DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·October 14, 2020
Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·May 26, 2021