11 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TYGON PAC-MONITORING LINES & FLUID ADMIN
FDA 510(k)
FDA Class 2
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517809353·Interlock II, 7x17x14mm 7°
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515200258·Kolbel Retractor blade, 20 x 85mm, pair
Young Specialties
FDA UDI
Young Innovations, Inc.·00843471188583·.022 U/L STD. COMB. WELD SZ#7
ORBITAL FLOOR PLATE
FDA Adverse Event
Injury
·SYNTHES·Product code JEY·March 28, 2016
RITTER STARLIGHT DENTAL OPERATING LIGHT
FDA 510(k)
FDA Class 1
·Dental
MICRUS MICROCOIL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 18, 2014
PUMP IN STYLE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·October 1, 2012
REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2010
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·October 3, 2012