14 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
POWDERFREE NITRILE PATIENT EXMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
SCANLAN® Legacy Micro Forceps
FDA UDI
SCANLAN INTERNATIONAL INC·00846159033441·Legacy FRCP FH C 1X2MT 0.5MM DD 8 1/4"
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 29, 2023
INTRODEUCE DOUBLE LUMEN INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS
FDA 510(k)
FDA Class 1
·General Hospital
BD VACUTAINER K3E 5.4MG PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 28, 2020
CATH INF.038 F4 100 JR-4
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code DQO·December 9, 2008
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST JUDE MEDICAL- NEUROMODULATION DIVISION·Product code LGW·February 24, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·February 25, 2008
ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø46
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·October 4, 2023
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
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
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022