26 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989025378·PREF.LING.ARCH NI-TI UP18 SZ1 PK/10
LATERALIZED AND AUGMENTED BASEPLATE
FDA UDI
FX SOLUTIONS·03701037316795·TA6V CEMENTLESS GLENOID BASEPLATE W/ PEG Ti/HA ...
OptiLIF Endo, Direct Visualization System
FDA UDI
SPINEOLOGY INC.·M7401050026·Endo Portal Head
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0100260·Tray Insert, Lumbar Screw Rack 10 x 10
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100260·Assembly, Caddie, Implants, Hinged
System, Laser, Photodynamic Therapy
FDA Pre-Market Approval
FDA Class 3
·QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410500260·Anterior Closing Wedge Osteotomy Guide, 50mm x ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420500260·Anterior Lateral Wedge Osteotomy Guide, 50mm x ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710300500260·Tibial Osteotmy Guide, 50mm x 26mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710400500260·Anterior Dome Osteotomy Guide, 50mm x 26mm
EMBOGOLD MICROSPHERE
FDA 510(k)
FDA Class 2
·Neurology
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
System, Laser, Photodynamic Therapy
FDA Pre-Market Approval
FDA Class 3
·Quantel Activis Laser, Modulight ML6710i Laser and ML-SLA, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters
System, Laser, Photodynamic Therapy
FDA Pre-Market Approval
FDA Class 3
·Qcellus Laser, Activis Laser, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters
System, Laser, Photodynamic Therapy
FDA Pre-Market Approval
FDA Class 3
·QCELLUS LASER
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·November 28, 2022
GPSIII 30ML PLATELET CONCENTRATION KIT WITH ACD-A
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KSS·August 22, 2018
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 10, 2013
LOANER SYSTEM 6 SAG SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·March 14, 2011