36 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828184663·GEN4 INTERACTIVE
VOLKMAN RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896049291·VOLKMAN RETRACTOR SHARP PRONGS
DEBAKEY MORRIS VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921006580·DEBAKEY MORRIS VASCULAR CLAMP ANGLED 2X3 JAW CU...
DEBAKEY MORRIS VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002944·DEBAKEY MORRIS VASCULAR CLAMP ANGLED JAW CURVED...
IMAGE DIAGNOSTICS INC
FDA UDI
IMAGE DIAGNOSTICS, INC.·00850977007232·IDI,TABLE,VERT.-TILT TABLETOP MOVEMENT,PAIN MAN...
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494462382·Hook Probe Knurled Handle Steel
D 3.0mm, WL 260mm
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012
ERS RADIAL HEAD REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFIED USS FRACTURE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FSA·May 8, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 12, 2011
Brilliance iCT Computed Tomography X-ray system, Model 728306
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016
Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018
Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016