1,692 results · 22ms · Sources: EU EUDAMED, US FDA

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Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120694·Guidewire 2.5x230mm Partially Thrd

Vilex Guidewire

FDA UDI
VILEX IN TENNESSEE, INC.·00841731120687·Guidewire 2.5x230mm Sgl Trocar

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Enforcement
Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

SacroFuse

FDA UDI
SPINEFRONTIER, INC.·00190361036258·SCREW, SOLID WALL, CANNULATED, Ø12MM X 55MM, SA...

SILICONE DUAL LUMEN RADPICC CATHETERS

FDA 510(k)
FDA Class 2 ·General Hospital

HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ACRYSOF TORIC

FDA Adverse Event
Other ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MJP·November 7, 2008

UNKNOWN DEPUY ASR HEAD

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KXA·September 1, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 16, 2013

Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

FDA Enforcement
Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 8, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·January 8, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 30, 2025

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·October 15, 2025

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·February 19, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026

BD VACUTAINER® SST¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 27, 2026