21 results
·
28ms
·
Sources: EU EUDAMED, US FDA
SONICAID FM820, SONICAID FM830
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Implant Prosthetics
FDA UDI
Preat Corporation·00842092116302·Astra®-compatible Aqua 3.5/4.0mm Titanium Impla...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092002150·artVeneer life upper posteriors, XL, D4
JBC
FDA UDI
FOREMOUNT ENTERPRISE CO., LTD.·04719871892305·Anesthesia Mask, Size 4,Adult
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159018226·Vascular Clamp 25 mm Jaw
Implant Prosthetics
FDA UDI
Preat Corporation·10842092116309·Astra Aqua 3.5/4.0mm Titanium Screw (10-Pack)
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540387400·DRILL GUIDE
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540387394·DRILL GUIDE
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 9, 2007
MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150
FDA 510(k)
FDA Class 1
·Hematology
ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNKNOWN DEPUY ACETABULAR LINER
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code HRY·March 13, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 4, 2011
N600 PULSE OXIMETER
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code DQA·February 25, 2008
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 27, 2025
DISP.TROCAR THRD.W.DILATING PIN 12/110MM
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code GCJ·July 9, 2019
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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