18 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Sklar®
FDA UDI
SKLAR CORPORATION·10649111118227·UTILITY SCISS SERR BLACK 6"
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390884365·
CORRIDOR4DM V2010 MODEL: V2010
FDA 510(k)
FDA Class 2
·Radiology
ENTEC EVAC PLASMA WAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CADD SOLIS VIP PUMPS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·June 3, 2022
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·August 18, 2022
BIOHORIZON DENTAL IMPLANT DRILL
FDA Adverse Event
Injury
·BIOHORIZONS·Product code DZA·May 9, 2013
SROM*EXTNSN,FEM.STM,BOW,15X150
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JWH·September 23, 2014
ADVANTAGE SERIES 26
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 18, 2011
SELECTSECURE MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVN·July 15, 2025
SELECTSECURE MRI SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code NVN·July 15, 2025
SELECTSECURE MRI SURESCAN
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code NVN·July 15, 2025
Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code MBI·April 23, 2019
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
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025