16 results
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19ms
·
Sources: EU EUDAMED, US FDA
Natural rubber latex male condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Vivid ZirDisc Wieland System
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724Q2500341·98mmx28mm 03HT (Translucent)
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813010365·NITI LEGACY MT CM S2 25MM
Snake Bite Kit - ZLB
FDA UDI
Certified Safety Manufacturing, Inc.·00766588050348·Snake Bite Kit - ZLB
Low Electric Field Generator For Pancreatic Cancer Treatment
FDA Pre-Market Approval
FDA Class 3
·Optune Pax
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250034400·ceraMotion® Zr Base Dentin D2, 40 g / dental ce...
devemed
FDA UDI
devemed GmbH·04061644022380·Compactor 5.0 / 4.0 mm
for bone grafting mater...
metene Enhance Blood Glucose Monitoring System
FDA UDI
HMD BIOMEDICAL INC.·00850009854032·Metene Enhance Blood Glucose Monitoring System
...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250034200·ceraMotion® Zr Base Dentin D2, 20 g / dental ce...
ELEOS
FDA Adverse Event
Injury
·ONKOS SURGICAL·Product code KRO·July 3, 2025
SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AMT Enteral Transition Adapters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDO·September 9, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·November 14, 2008
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·July 26, 2013
CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient
FDA Enforcement
Class II
·Ongoing·GE Healthcare Finland Oy·July 3, 2024