28 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450182796·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450047613·
NA
FDA UDI
STRYKER CORPORATION·07613327052817·Insert, Double-Action Biopsy Spoon with Pin
ITI DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MFCD 118
FDA 510(k)
FDA Class 2
·Radiology
QUICK COMBO PAD
FDA Adverse Event
Injury
·PHYSIO CONTROL CORP.·Product code MLN·January 17, 1997
WAVEWRITER ALPHA? PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 30, 2025
INFINION CX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 7, 2025
CORE SUMEX DRILL WITH KNURL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·April 26, 2013
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·March 30, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008
BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·September 24, 2014
REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Ongoing·ICU Medical, Inc.·May 19, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 20, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 30, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 20, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 20, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 22, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 22, 2021