9 results · 11ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code JEA·September 19, 2024

Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code JEA·September 19, 2024

Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code JEA·September 19, 2024

Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code JEA·September 19, 2024

Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

FDA Recall
Open, Classified ·Zoe Medical Incorporated·Product code DQA·August 13, 2024

Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152 The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.

FDA Recall
Open, Classified ·Spectranetics Corporation·Product code MCW·November 15, 2023

Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-135-01 / 989930004171 / 2.3 mm OTW 423-135-02 / 989930004181 / 2.3 mm OTW 425-135-01 / 989930004201 / 2.5 mm OTW 425-135-02 / 989930004211 / 2.5 mm OTW The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.

FDA Recall
Open, Classified ·Spectranetics Corporation·Product code MCW·November 25, 2024

Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

FDA Recall
Open, Classified ·Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438·Product code MCW·February 5, 2025

AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code MCW·November 25, 2024