15 results · 21ms · Sources: EU EUDAMED, US FDA

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SENZZZZZ AWAY

FDA 510(k)
FDA Class 2 ·Dental

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00810019801129·Towel, Circ NS

ARGEDENT 500 (5 dwt)

FDA UDI
ARGEN CORPORATION, THE·D818120176·Gold based noble metal

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00812564035639·Towel, Circ NS

Diversatek Healthcare

FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201760·Endoscopy Basic Procedure Kit

EPOC READER, HOST

FDA Adverse Event
Malfunction ·EPOCAL INC.·Product code CGL·October 26, 2020

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·April 15, 2002

HDR MIAMI APPLICATOR

FDA 510(k)
FDA Class 2 ·Radiology

ASCENSION ANKLE FUSION PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 3, 2024

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 10, 2023

SM104 MSERIES W5TH WHLOBS3/07

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 20, 2013

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code IOR·September 25, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011

Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

FDA Enforcement
Class II ·Terminated·GA Industries·May 6, 2015