14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MONTAGE-QS Settable, Resorbable Hemostatic Bone
FDA 510(k)
FDA Unclassified
·Unknown
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365108525·
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365114632·
EXPERIENCE®
FDA UDI
Gc Orthodontics America Inc.·D78819114000101·EXMRC ROTH 018/UR 4 & 5 - 7T 0A 2D
EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO
FDA 510(k)
FDA Class 2
·General Hospital
DENTLIGHT ORAL EXAM LIGHT KIT
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
SINGLE LUMEN 1.9FR SILICONE PICC PROCEDURAL KIT
FDA Adverse Event
Malfunction
·FOOTPRINT MEDICAL INC.·Product code LJS·December 4, 2019
M2A 38MM MODULAR HEAD STD NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 21, 2014
CONNECTSTAT
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 19, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 26, 2013
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·December 29, 2023
XP-XP Tibial Tray - Interlok 69 mm Item # 195754
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016