15 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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Obsidian® NOW
FDA 510(k)
FDA Class 2
·Dental
Sonoma™
FDA UDI
Seaspine Orthopedics Corporation·10889981051549·Bone Screw, Variable, Double Lead, 4.0 x 14mm
Insignia
FDA UDI
ALPHATEC SPINE, INC.·00190376266619·4.0mm Fixed Angle, Self Tapping Screw, Dual Lea...
HORICO
FDA UDI
Hopf, Ringleb & Co. GmbH & Cie.·EHORFG2340142·Rotary diamond instrument
Manta Ray™
FDA UDI
Seaspine Orthopedics Corporation·10889981057510·Screw - Self-Tapping - Variable - 4.0x14mm
HORICO
FDA UDI
Hopf, Ringleb & Co. GmbH & Cie.·EHORFG2340145·Rotary diamond instrument
FG Dental Burs
FDA UDI
BIOLINE DENTAL IMPLANT SYSTEMS LTD·07290119312023·
TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)
FDA 510(k)
FDA Class 2
·Cardiovascular
SPI CONTACT DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
ANTERIOR CERVICAL PLATE 2 LEVEL 31MM
FDA Adverse Event
Malfunction
·SEASPINE, INC.·Product code JDN·May 8, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014
VA-LCP CONDYLAR PLATE 4.5/5.0 R 12HO L26
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code JDP·August 31, 2011
SEVO-S
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 11, 2013
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·March 1, 2023