19 results
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
FDA Enforcement
Class II
·Ongoing·Future Diagnostics Solutions B.V.·February 1, 2023
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·November 5, 2025
Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·June 10, 2020
Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 13, 2020
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·October 20, 2021
Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 FLX-207-00, FLX-207-01, FLX-207-02, FLX-230-00, FLX-230-01, FLX-230-02 FLX-207-10, FLX-207-11, FLX-230-10
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 10, 2023
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·September 25, 2024
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·September 25, 2024
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95
FDA Enforcement
Class I
·Ongoing·Qapel Medical Inc.·April 16, 2025
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·May 10, 2023
Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN HEART MHS, Model Number DYNJ905394B, g. OPEN HEART WPH, Model Number DYNJ908168 Model/Catalog Number: Model Numbers: a. CDS984642, b. DYNJ902880J, c. DYNJ902880K, d. DYNJ904831F, e. DYNJ905394A, f. DYNJ905394B, g. DYNJ908168 Product Description: convenience kits labeled as follows:
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - SPT·August 3, 2022
Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - SPT·August 3, 2022
Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860A
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - SPT·August 3, 2022
Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - SPT·August 3, 2022
Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - SPT·August 3, 2022
Z-1477-2022
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - SPT·August 3, 2022
Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK Model/Catalog Number: Model Numbers: a.DYNJ0397191V, b. DYKMBNDL138, c. DYNJ907374, d. DYKMBNDL40A, e. DYNJ908260, f. DYNJ21243M, g. DYNJ904818D, DYNJ905194, DYNJ904040D, DYNJ904040F, DYNJ904818C, DYNJ905753A, h. DYNJ0101287I, i. DYNJ21244N, j. DYNJ46530J
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - SPT·August 3, 2022
Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i. EVLP Pack/Kit, j. GENERAL PURPOSE CV, k. GENERAL PURPOSE CV, l. KIT GERMANTOWN CABG, m. KIT GERMANTOWN CABG, n. DENTAL RESTORATIONS, o. ALCOHOL PREP PACK, p. ALCOHOL PREP PACK, q. MATRIXECTOMY PACK-LF Model/Catalog Number: a. CDS981543D, b. DYKM1875, c. DYKMBNDL142A, d. DYKMBNDL142A, e. DYKS1185A, f. DYNJ0842793F, g. DYNJ0842793F, h. DYNJ0843063J, i. DYNJ901205C, j. DYNJ904395F, k. DYNJ904395F, l. DYNJ905855, m. DYNJ905855, n. DYNJ906653A, o. P922260, p. P922260, q. PHS110395003
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - SPT·August 3, 2022
Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·August 14, 2024