246 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RAUMEDIC ICP MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
BioCare Safety Needles
FDA UDI
BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"
New Image
FDA UDI
HOLLISTER INCORPORATED·00610075073122·2-Piece Ostomy Skin Barrier, CeraPlus
Globe Scientific
FDA UDI
GLOBE SCIENTIFIC INC.·00840095601214·Tube, Urine Centrifuge, 12mL, with Flared Top, ...
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750006007·SALIVA COLLECTOR MPORT LG 6926
MEGA PLUS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809155857130·Rod, Ø6.0 x 170mm
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869628419·MOSS VRS MIS Ti polyaxial long head extended tabs
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869655514·MOSS VRS MIS in:situ Ti reduction head extended...
VARISEED 7.0
FDA 510(k)
FDA Class 2
·Radiology
SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·July 29, 2022
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·May 2, 2013
BIOMET BIOCHILL
FDA Adverse Event
Injury
·EBI, LLC·Product code ILO·June 2, 2011
FOUNDATION KNEE SYSTEM
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JWH·August 14, 2008
BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·June 10, 2022
PINN SECTOR W/GRIPTION 58MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 24, 2017
I-STAT1 ANALYZER, IMMUNO READY, WIRELESS
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code CGA·March 16, 2022
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. 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
2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·March 14, 2018
Spine Pack , part number AMS3753(A Spine Pack, part number AMS3783(A Spine Pack, part number AMS3783(B Spine Pack, part number AMS6472
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017