12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TE Air Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
MaXcess
FDA UDI
Nuvasive, Inc.·00887517191243·MaXcess Access Spreader, Blade Rotation
Symmetry Davis
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482036822·Symmetry® Spatula, Davis Brain, 1/4 in, 7 in, 1...
TriVerse I-Beam Solid Punch
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215097516·
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127029950·Bipolar Head Assembly, Size 51mm
PUGGLE Enteral Feeding Pump and Feeding Set
FDA 510(k)
FDA Class 2
·General Hospital
SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
FDA 510(k)
FDA Class 2
·Anesthesiology
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962113608·DAVIS BRAIN SPATULA, 1/4"X7"
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·October 31, 2008
MCS+8150
FDA Adverse Event
Malfunction
·HAEMONETICS CORP.·Product code GKT·August 9, 2011
ATLAS II PLUS HF CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023