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

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MEDLINE STOPCOCK AND MANIFOLD

FDA 510(k)
FDA Class 2 ·Cardiovascular

Chemosite

FDA UDI
Covidien LP·10884521099050·Line Extension Set

ArgenIs

FDA UDI
ARGEN CORPORATION, THE·D818120069·Dental prosthesis/implant abutment screw A non...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694002684·Medium 2 x 4 Hole Quad Plate

OsteoMed

FDA UDI
OSTEOMED LLC·00845694047562·Medium 2 x 4 Hole Quad Plate, Sterile

CADD CASSETTE 100ML W/FLOWSTOP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code LHI·March 2, 2022

OsteoMed

FDA UDI
OSTEOMED LLC·00845694063616·1.2 System Hole 2 x 4 Quad Plate Sterile Qty 2

MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

JOURNEY UNICONDYLAR TIBIAL BASEPLATES

FDA 510(k)
FDA Class 2 ·Orthopedic

Widex

FDA UDI
Widex A/S·05706069794397·Widex EVOKE E-FP (Summer gold ) 220, Telecoil, ...

Widex

FDA UDI
Widex A/S·05706069807301·Widex EVOKE E-FM (Summer gold ) 220, RC coil

Widex

FDA UDI
Widex A/S·05706069818086·Widex UNIQUE U-FP (Summer gold ) 220, Telecoil,...

Widex

FDA UDI
Widex A/S·05706069817737·Widex UNIQUE U-FM (Summer gold ) 220, RC coil

Widex

FDA UDI
Widex A/S·05706069817140·Widex UNIQUE U-FA (Summer gold ) 220, Telecoil,...

Widex

FDA UDI
Widex A/S·05706069806236·Widex EVOKE E-FA (Summer gold ) 220, Telecoil, ...

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·September 25, 2014

LIFEPAK 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·August 15, 2008

MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

FDA Enforcement
Class II ·Ongoing·Auris Health, Inc·February 25, 2026

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