392 results
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10ms
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Sources: EU EUDAMED, US FDA
8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
FDA Enforcement
Class II
·Ongoing·Intuitive Surgical, Inc.·January 22, 2025
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
FDA Enforcement
Class II
·Ongoing·Intuitive Surgical, Inc.·January 22, 2025
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·February 9, 2022
Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
FDA Enforcement
Class II
·Ongoing·C.R. Bard Inc·September 29, 2021
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024
ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
FDA Enforcement
Class II
·Ongoing·Johnson & Johnson Vision Care, Inc.·July 30, 2025
Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]
FDA Enforcement
Class II
·Ongoing·Draeger Medical Systems, Inc.·June 28, 2023
Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Stimulation Probe, 90mm, and 1 Green Ground Needle ; REF 1-D-BMF90-5, lot number 050925219, expiration 2028-11-30 I-D-BMF90-5 Stimulated EMG Kit with Hummingbird - Box of 5 Kits - Each Kit Includes: 1 Single-Use Bipolar Minifork Stimuation Probe, 90mm, and 1 Green Ground Needle
FDA Enforcement
Class II
·Ongoing·Neurovision Medical Products Inc·July 16, 2025
Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·April 29, 2026
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
FDA Enforcement
Class II
·Ongoing·Withings·March 29, 2023
MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; 2) PK CUST CV A&B CABRINI CO, Medline Kit Number/SKU DYNJ60583C.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·June 24, 2026
Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUBLAN PREMIUM OXYGEN 1 DAY TORIC, EV LINARIAL TORIC (30), EYEXPERT PURE ASTIGMATISM (30), LENTI!!AS A ASTIGMATISMO 30PK, LENTSOFT DIARIA CONFORT+ SILICONA ASTIGMATISMO, MULTILENS CONTACT ELITE SILICONE 1 DAY TORICS, OPTIONS SUPREME 1 DAY TRC (30), PRIMA + 1 DAY ASTGM (30), PROTECT PLATINUM FOR ASTG (30), SOL- LENS 1 DAY SILICONE PREMIUM TORIC, UGO LENS DAY ADVANCED TORICA, WHITE BOX STENFILCON A TORIC 07536, MEDIFLEX SUP 1D TORIC, Kirkland Signature Toric Premium Daily Disposable, Specsavers easyvision Linarial Toric. Product Name: (Stenfilcon A) Contact Lens Model/Catalog Number: MyDay Toric Product Description: 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged. Component: No
FDA Enforcement
Class II
·Ongoing·CooperVision, Inc.·April 2, 2025
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·June 24, 2026
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company·May 27, 2026
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company·May 27, 2026
Swan-Ganz Pacing Catheter, Models: D200F7;
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company·May 27, 2026
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·May 6, 2026
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·March 18, 2026
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·May 6, 2026
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·December 24, 2025