392 results · 10ms · Sources: EU EUDAMED, US FDA

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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