6 results · 6ms · 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.

STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].

FDA Enforcement
Class II ·Ongoing·Ethicon, Inc.·May 18, 2022

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

AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.

FDA Enforcement
Class II ·Ongoing·MRP, LLC dba Aquabiliti·February 28, 2024

GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

FDA Enforcement
Class II ·Ongoing·GE Healthcare GmbH·December 24, 2025