17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VENOTRAIN CURAFLOW
FDA 510(k)
FDA Class 2
·General Hospital
Bone cutters
FDA UDI
DFS - DIAMON GmbH·04057176148179·Bone Cutter type 166 HP
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317347558·
SYNAPSE 3D BASIC TOOLS
FDA 510(k)
FDA Class 2
·Radiology
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
FDA 510(k)
FDA Class 2
·Immunology
FIBULA COMP LOCK PLATE 10H STE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HRS·August 24, 2016
CORONOID PLATE RT STE
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HRS·June 9, 2016
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·May 14, 2013
ITREL 3
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·August 13, 2008
RF3000 RADIOFREQUENCY GENERATOR
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEI·June 2, 2011
S3 SHOULDER PLATE 4 HOLE RIGHT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LXT·March 4, 2013
OPEN-END FLEXI-TIP URETERAL CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KOD·February 6, 2020
OPEN-END URETERAL CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KOD·February 7, 2020
OPEN-END URETERAL CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KOD·December 5, 2019
PROXIMATE*HCS HEMORR CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 26, 2019
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021