57 results · 22ms · 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.

Athena III Cervical Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

HHM

FDA UDI
Sbo Hearing A/S·05714464029754·HHM F400 MINIRITE T C090

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183747·Integra® Jarit® Liston Bone Cutting Forceps, 5-...

Intrigue

FDA UDI
LANCER ORTHODONTICS, INC.·00817573020652·INTRG WHISP-Z MBT CEN +17T +4A 022 UR

Vasomedical-Biox™ 2303 Combined 3 Channel ECG Holter & ABP Monitor

FDA UDI
VASOMEDICAL, INC.·00817980020092·3 CH ECG Holter/ABP COMBINED Recorder

UNICONDYLAR FEMORAL COMPONENT

FDA 510(k)
FDA Class 2 ·Orthopedic

LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

T:FLEX INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code LZG·February 8, 2019

MEDFUSTION 3500 SYRINGE INFUSION PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL MD, INC.·Product code FRN·October 21, 2014

UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code MMI·September 1, 2011

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 16, 2013

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

AxioGlass

FDA UDI
Axiodent Inc.·D161230300·

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

BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code JKA·March 5, 2025

BD MINIDRAW¿ FINGER SLEEVE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code GIM·February 27, 2025

BD MICROLANCE CONVENTIONAL NEEDLES

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·June 17, 2024

BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code GIM·August 6, 2024

BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 29, 2025

BD MINIDRAW¿ FINGER SLEEVE, EXTRA-LARGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·October 29, 2025