181 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case; e. Glove 8.5 Pack, 25 Pairs, 10 packs per case; f. Glove 9.0 Pack, 25 Pairs, 10 packs per case;
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX Station Pharmacy Compounding System.
FDA Enforcement
Class II
·Ongoing·Omnicell, Inc.·April 16, 2025
Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 11, 2023
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
FDA Enforcement
Class I
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 18, 2023
CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 20, 2024
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, INc.·November 15, 2023
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 11, 2026
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 11, 2026
Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs). Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.
FDA Enforcement
Class II
·Ongoing·Medical Action Industries Inc·May 24, 2017
3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary carton, and 4 primary cartons per shipper box.
FDA Enforcement
Class II
·Ongoing·3M Company - Health Care Business·April 10, 2024
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·October 2, 2024
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·October 2, 2024
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software.
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·October 2, 2024
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.
FDA Enforcement
Class II
·Ongoing·Medtronic Perfusion Systems·June 1, 2022
MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12T b. TRACH DOUBLE SWIVEL, 14 Fr, Item Number/REF: DYNCPDS14T
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 5, 2022
MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14; b. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14T
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·October 5, 2022
(1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS; (2) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546D, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 1, 2023