14 results · 15ms · Sources: EU EUDAMED, US FDA

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Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

FDA Recall
Open, Classified ·Product code KIE·October 9, 2024

Atrium Pneumostat Chest Drain Valve, Part Number 16100

FDA Recall
Open, Classified ·Atrium Medical Corporation·Product code KDQ·August 26, 2021

CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).

FDA Recall
Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code OSR·April 6, 2021

Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110SN/D, 28MC24110ST/D, 28MC2413045/D, 28MC24130SN/F, 28MC24130ST/D, 28MC24130ST-W/A, 28MC2415045/D, 28MC24150ST/D, 28MC24150ST/F, 28MC28110ST/D, 28MC2813045/D, 28MC28130SN/D, 28MC28130SN/F, 28MC28130ST/D, 28MC28150SN/D, 28MC28150SN/F, 29MC2911045/D, 29MC29130SN/F, 29MC29130ST/D, 29MC29150ST/CNB, 29MC29150ST/D, CE 2797, STERILEEO, Rx ONLY

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code KRA·November 6, 2023

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component

FDA Recall
Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025

VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);

FDA Recall
Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025

Alcohol (ALC) Test Saliva

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DIC·November 3, 2025

VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);

FDA Recall
Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component

FDA Recall
Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025

Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

FDA Recall
Open, Classified ·DRE Medical Group Inc·Product code MNT·May 15, 2023

Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

FDA Recall
Open, Classified ·Skytron, Div. The KMW Group, Inc·Product code FQO·March 5, 2020

Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32

FDA Recall
Open, Classified ·Skytron, Div. The KMW Group, Inc·Product code FQO·May 11, 2021

Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

FDA Recall
Open, Classified ·Skytron, Div. The KMW Group, Inc·Product code FQO·June 2, 2022

3mensio Workstation (Vascular Fenestrated) software

FDA Recall
Open, Classified ·PIE Medical Imaging B.V. Demertdwarsstraat 8A01 Maastricht Netherlands·Product code LLZ·July 14, 2025