11 results · 38ms · Sources: EU EUDAMED, 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