11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cantab Mobile
FDA 510(k)
FDA Class 2
·Neurology
Deploy™ Expandable Interbody System
FDA UDI
Southern Spine LLC·00815351022584·Lumbar Expandable Cage, 16 Degree, 28mm Length,...
CoRoent
FDA UDI
Nuvasive, Inc.·00887517577863·CoRoent Ant TLIF PEEK, 16x11x32mm 4°
Symmetry Rochester Ochsner
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482056226·Symmetry® Forceps, Rochester-Oschner, Curved, 1...
THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENSITE VELOCITY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2014
RETAIN-SLEEVE LONG F/MATRIX 5.5
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
FDA Enforcement
Class II
·Terminated·Cardiovascular Systems Inc·May 31, 2017