20 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BAHADIR STERILIZATION TRAYS
FDA 510(k)
FDA Class 2
·General Hospital
N/A
FDA UDI
MEDTRONIC XOMED, INC.·00763000034702·PROSTHESIS 1112090 H/A PARTIAL 90 ROUND
N/A
FDA UDI
MEDTRONIC XOMED, INC.·00763000913632·PROSTHESIS 1112090 H/A PARTIAL 90 ROUND
NA
FDA UDI
MEDTRONIC XOMED, INC.·00681490033367·PROSTHESIS 1112090 H/A PARTIAL 90 ROUND
Integrity-SI Fusion System
FDA UDI
Lincotek Medical LLC·B57112521112090D0·12 x 90 mm Anodized SI Implant Fully Threaded
BD E-Z SCRUB¿
FDA Adverse Event
Injury
·CAREFUSION, INC·Product code OJU·December 20, 2021
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWI·January 25, 2017
ACRYSOF
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·May 7, 2013
SPEEDPASS DISPOSABLE SUTURE LARIAT W/NITINOL WIRE
FDA Adverse Event
Injury
·BIOMET SPORTS MEDICINE·Product code MDM·June 2, 2011
CENTRA 850 BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 6, 2008
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018
8MM TI STRAIGHT RADIAL STEM 28MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·January 24, 2017
22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·January 24, 2017
18MM COCR RADIAL HEAD STANDARD HEIGHT/11.5MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·September 7, 2017
7MM TI STRAIGHT RADIAL STEM 26MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code KWI·September 7, 2017
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023