62 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SynchroWave Antenna Kit
FDA UDI
PERSEON CORPORATION·00851551005064·15cm Long Tip Antenna and Cooling Circuit
MicroThermX Microwave Ablation System
FDA UDI
PERSEON CORPORATION·00851551005002·MicroThermX Microwave Ablation System - Mobile ...
SynchroWave Antenna Kit
FDA UDI
PERSEON CORPORATION·00851551005095·20cm Short Tip Antenna and Cooling Circuit
SynchroWave Antenna Kit
FDA UDI
PERSEON CORPORATION·00851551005156·25cm Long Tip Antenna and Cooling Circuit
SynchroWave Antenna Kit
FDA UDI
PERSEON CORPORATION·00851551005071·20cm Long Tip Antenna and Cooling Circuit
SynchroWave Antenna Kit
FDA UDI
PERSEON CORPORATION·00851551005088·15cm Short Tip Antenna and Cooling Circuit
MicroThermX Microwave Ablation System
FDA UDI
PERSEON CORPORATION·00851551005019·MicroThermX Microwave Ablation System - Tableto...
SYNCHROWAVE ANTENNA LT
FDA Adverse Event
Injury
·PERSEON CORPORATION·Product code NEY·December 16, 2016
Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·August 19, 2015
Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.
FDA Enforcement
Class II
·Terminated·Crimson Trace Corporation·May 2, 2018
Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. DIANEAL Low Calcium peritoneal dialysis solutions are indicated for use in chronic renal failure patients being maintained on peritoneal dialysis. - and- The Personal Cycler Peritoneal Dialysis System [cycler and ancillary sets] is used for automatic control of dialysate solution exchanges in treatment of renal failure patients undergoing peritoneal dialysis. The Personal Cycler System automatically cycles a prescribed volume of dialysis solution into and out of the peritoneal cavity during the dialysis treatment.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Renal Div·August 8, 2012
TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, FDX-MCG. Mrf. By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035. Intended to provide mobility to a person restricted to a sitting position.
FDA Enforcement
Class II
·Terminated·Invacare Corporation·July 11, 2012
HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·August 23, 2017
HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·August 23, 2017
Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
FDA Recall
Terminated
·Invacare Corporation·Product code ITI·February 2, 2015
Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.
FDA Recall
Terminated
·Crimson Trace Corporation·Product code REU·October 10, 2017
Leo 3-Wheel Scooter and Leo Scooter, Distributed By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035 Intended to provide transportation for a disabled or elderly person.
FDA Recall
Terminated
·Invacare Corporation·Product code INI·December 7, 2011
HydroSil (Intermittent Catheter) Hydrophilic 14 French Male Length REF#63614 Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.
FDA Recall
Terminated
·Rochester Medical Corp·Product code KOD·January 14, 2009
HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length Sample Packs REF#63612SPL Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.
FDA Recall
Terminated
·Rochester Medical Corp·Product code KOD·January 14, 2009
HydroSil (Intermittent Catheter), Hydrophilic 12 French Male Length REF#63612 Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. Intended for use for bladder management including urine drainage, collection and measurement.
FDA Recall
Terminated
·Rochester Medical Corp·Product code KOD·January 14, 2009