14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HUMELOCK CEMENTED SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Bone cutters
FDA UDI
DFS - DIAMON GmbH·04057176147868·Bone cutter Carboss Supra
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033986·Source Position Simulator with Markers for micr...
Sklar
FDA UDI
SKLAR CORPORATION·10649111457593·METZENBAUM-FINO SCISS 200MM 8 IN
CALGAESEAL MODEL: CAS
FDA 510(k)
FDA Unclassified
·Unknown
QUICKVUE DIPSTICK STREP A
FDA 510(k)
FDA Class 1
·Microbiology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 4, 2022
MAVERICK2 BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 14, 2013
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FRN·September 23, 2014
CERVIX APPLICATOR SET WITH CT-CYLINDERS
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS HAAN GMBH·Product code JAQ·May 20, 2011
NUTRILINE
FDA Adverse Event
Malfunction
·VYGON USA·Product code LJS·August 12, 2022
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025