14 results
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26ms
·
Sources: EU EUDAMED, US FDA
GN BROTH
FDA 510(k)
FDA Class 1
·Microbiology
DD cube ONE ML
FDA UDI
Dental Direkt GmbH·EDDIG8340161·DD cube ONE® ML are dental mill blanks made fro...
FG Dental Burs
FDA UDI
BIOLINE DENTAL IMPLANT SYSTEMS LTD·07290119312481·
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM51008343140161·Rotary diamond instrument for dental application
Continuum® Trilogy®
FDA UDI
Zimmer, Inc.·00889024154209·
Continuum® Trilogy®
FDA UDI
Zimmer, Inc.·00889024154193·
VASCUTEK VASCULAR PROTHESIS VP1200K/50K
FDA 510(k)
FDA Class 2
·Cardiovascular
ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER
FDA 510(k)
FDA Class 2
·Radiology
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120303341·Diamond, medium grit
VerSys®
FDA UDI
Zimmer, Inc.·00889024135987·
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 27, 2014
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·November 15, 2012
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 14, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018