15 results · 20ms · Sources: EU EUDAMED, US FDA

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MMN-1 COARSE MANIPULATOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ODYSSEY®

FDA UDI
Microport Orthopedics Inc.·M684K00126531·

RMO

FDA UDI
Rmo, Inc.·00885797099754·LING RETNR BOND 4X4 6 CASE KIT

BD SYRINGE LUER-LOK¿ TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 11, 2018

CONTACT DETACH

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 31, 2026

AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002

FDA 510(k)
FDA Class 2 ·Anesthesiology

XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY

FDA 510(k)
FDA Class 2 ·Orthopedic

ULTRASONIC DISSECTOR QTY OF 6

FDA Adverse Event
Malfunction ·COVIDIEN LP·Product code LFL·February 13, 2013

LIGASURE ATLAS HANDSWITCHING 37CM

FDA Adverse Event
Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·February 8, 2011

ACCU-CHEK COMPACT TEST DRUM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 8, 2008

UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024