18 results · 25ms · Sources: EU EUDAMED, US FDA

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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