11 results
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20ms
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Sources: EU EUDAMED, US FDA
MODEL ASYM-100
FDA 510(k)
FDA Class 2
·Radiology
Couture Essence
FDA UDI
Carolon Company·00078301930234·
N/A
FDA UDI
Tyber Medical, LLC·M695M9302130·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515237582·Cottle Hammer, 30mm dia, 300gms, 7 1/2"
ORTHOMED
FDA UDI
ORTHO-MED, INC.·B8039302130·LONG COBB CURETTE 15" CURVED #6
ONLINE DAT II CANNABINOIDS II
FDA 510(k)
FDA Class 2
·Clinical Toxicology
QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEGA NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·January 25, 2013
CAPIOX SX OXYGENATOR W/ HARDSHELL RESERVOIR
FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTZ·December 8, 2010
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 11, 2014
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013