11 results · 15ms · 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.

PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A

FDA Recall
Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·March 10, 2023

EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile

FDA Recall
Open, Classified ·Ortho8, Inc.·Product code JOW·July 9, 2021

CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,

FDA Recall
Open, Classified ·Ortho8, Inc.·Product code JOW·July 9, 2021

Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No

FDA Recall
Open, Classified ·Diagnostica Stago, Inc.·Product code DAP·February 5, 2026

Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.

FDA Recall
Open, Classified ·Vyaire Medical, Inc. Leibnizstr. 7 Hochberg Germany·Product code BZC·April 8, 2024

IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code PCT·May 21, 2024

Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

FDA Recall
Open, Classified ·Karl Storz Endoscopy·Product code NVT·October 21, 2024

IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;

FDA Recall
Open, Classified ·Angiodynamics, Inc.·Product code PCT·February 4, 2025

REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile

FDA Recall
Open, Classified ·Stryker Sustainability Solutions·Product code JOW·April 14, 2023

REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L

FDA Recall
Open, Classified ·Compass Health Brands (Corporate Office)·Product code IRP·March 7, 2023

Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323

FDA Recall
Open, Classified ·Abiomed, Inc.·Product code PYX·June 29, 2023