16 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OT EQUATOR
FDA 510(k)
FDA Class 2
·Dental
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100752·FLIERINGA FIXATION RING 14MM
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383552608·Gutta Percha Points is used to root canal filin...
X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·June 30, 2011
RADIAL JAW 3 SINGLE - USE BIOPSY FORCEPS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCL·September 17, 2008
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·April 15, 2022
BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code FTM·July 19, 2012
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·September 11, 2024
PANTHER FUSION ADV/HMPV/RV ASSAY
FDA Adverse Event
Injury
·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021
PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021
PERFORMER RADIAL ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·July 15, 2022
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021