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