30 results · 25ms · Sources: EU EUDAMED, US FDA

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4K UHD Camera System

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

OsteoMed

FDA UDI
OSTEOMED LLC·00845694011006·Compression Plate Drill Guide, 2.0mm

FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060579·FORCEPS TUNGSTEN CARBIDE DUST PLATFORM RING TIP...

OPERATING SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896054561·OPERATING SCISSORS STRAIGHT SHARP TIPS POWER CU...

uCT 530, uCT 550

FDA 510(k)
FDA Class 2 ·Radiology

PSK ENDOSCOPE CLEANING SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 5, 2022

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·April 14, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 21, 2021

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

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

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 13, 2023

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAB

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 13, 2017

EMBLEM MRI S-ICD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·September 18, 2024

EMBLEM S-ICD

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·September 18, 2024

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

THERASPHERE

FDA Adverse Event
Death ·MDS NORDION·Product code KXK·April 16, 2003

IPUMP PAIN MANAGEMENT SYSTEM

FDA Adverse Event
Injury ·BAXTER HEALTHCARE (SG)·Product code MEA·November 12, 2002

BIOGLUE SURGICAL ADHESIVE

FDA Adverse Event
Injury ·CRYOLIFE, INC.·Product code MUQ·August 11, 2011

ON-Q C-BLOC

FDA Adverse Event
Other ·I-FLOW CORP.·Product code MEB·October 1, 2008

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 1, 2013