15 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
FDA Enforcement
Class II
·Ongoing·SURGICAL SPECIALTIES·April 24, 2024
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
FDA Enforcement
Class II
·Ongoing·PATH·December 24, 2025
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·March 27, 2024
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
FDA Enforcement
Class II
·Ongoing·Medtronic Inc·January 21, 2026
20" Lead Wires, Replacement Part Number: 1067724-2
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
48" Lead Wires, Replacement Part Number: 1067724-4
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716
FDA Enforcement
Class II
·Ongoing·EBI, LLC·May 1, 2024
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
FDA Enforcement
Class I
·Ongoing·Erbe USA Inc·April 1, 2026
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
FDA Enforcement
Class II
·Ongoing·Erbe Medical, LLC·May 13, 2026
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
FDA Enforcement
Class I
·Ongoing·Erbe USA Inc·April 1, 2026
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
FDA Enforcement
Class I
·Ongoing·Erbe USA Inc·April 1, 2026
MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2) GYN VAGINAL, Medline Kit Number/SKU DYNJ912219; 3) KIT MAJ VAG SET UP, Medline Kit Number/SKU DYNJ907033B; 4) MINOR VAG PACK, Medline Kit Number/SKU DYNJ68663B; 5) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099F; 6) OB DELIVERY PACK, Medline Kit Number/SKU DYNJ14099G; 7) OB PACK, Medline Kit Number/SKU DYNJ03387B; 8) OB PACK, Medline Kit Number/SKU DYNJ03387C; 9) OB PACK, Medline Kit Number/SKU DYNJ53543B; 10) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645D; 11) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645F; 12) RR-D/E PACK, Medline Kit Number/SKU DYNJ62645G; 13) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454K; 14) VAGINAL DELIVERY PACK, Medline Kit Number/SKU DYNJ04454L; 15) VAGINAL PACK, Medline Kit Number/SKU DYNJ01830G.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 24, 2026