82 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017729·K-Wire, Double Ended, Trocar Point, Diameter Si...
MEGA PLUS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809155852333·Rod, Ø6.0 x 220mm
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0120220·Assembly, Screwdriver, Extended Tab
ALIF Disc Prep
FDA UDI
Life Spine, Inc.·00190837080044·
IMPACT RIMLOC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304221031·
WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S
FDA 510(k)
FDA Class 2
·Cardiovascular
CAROTID COIL
FDA 510(k)
FDA Class 2
·Radiology
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857242074·Rod Holding Forceps
FEMORAL IMPACTOR HEAD ASSEMBLY
FDA Adverse Event
Malfunction
·CONFORMIS·Product code HSX·May 1, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 2, 2011
FOUNDATION KNEE SYSTEM
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSH·August 14, 2008
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EFB·December 6, 2018
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EFB·December 6, 2018
ONYX
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·November 10, 2024
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·February 11, 2020
BD CONVENTIONAL SYRINGE 50ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 14, 2022
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·June 3, 2020
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Abbott Molecular, Inc.·October 20, 2021
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Enforcement
Class I
·Terminated·Abbott Molecular, Inc.·October 20, 2021