11 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)
FDA 510(k)
FDA Class 2
·Radiology
TP Original Wire
FDA UDI
TP ORTHODONTICS INC·00192029029008·Premier Plus Round
Sochi
FDA UDI
Altus Spine, LLC·00843210168029·Clamshell, Connector, 3.5mm to 3.5mm
Atoll
FDA UDI
Seaspine Orthopedics Corporation·10889981033712·Clamshell 3.5mm to 3.5mm Connector Asm. The Ato...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
NUVASIVE EMG ENDOTRACHEAL TUBE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 2, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024