18 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITAL-PORT(TM) M.R.I. VASCULAR ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ZAVATION
FDA UDI
Zavation LLC·00842166151550·WHITNEY 13mmx15mm , 0deg , 05mm
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756964449·STROKE PLASTIC PACK
Rampart One Lumbar Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7404910005·Fixed Angle Driver Tip
Sapphire ULTRA Coronary Dilatation Catheter
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955979019·
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869668521·MOSS VRS Ti Cross Connector, bridged 35-69mm
CYNOSURE PHOTOGENICA DL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD PLASTIPAK HYPODERMIC LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 18, 2020
LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X260MM X 12
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 6, 2012
ENDOTAK ENDURANCE EZ
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·January 11, 2013
MAGIC TORQUE GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·November 30, 2010
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 2, 2014
SPINAL NEEDLE 22GA 3.50 IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·October 7, 2020
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
FDA Enforcement
Class II
·Ongoing·Pro-Med Instruments Gmbh·June 4, 2025
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;
FDA Enforcement
Class II
·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode.
FDA Enforcement
Class II
·Terminated·Cyberonics, Inc·August 23, 2017
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024