18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Edge™ Diamond PC014-6.5M Parallel Chamfer
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172005937·Diamond dental bur, reusable
MICROZYME THC ENZYME IMMUNOASSAY TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FOUR TANK DISSOLUTION MODULE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EXT SET, PUR SMALLBORE BIFUSE W/2 CLAVE¿
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·October 3, 2025
RATCHETING SCREWDRIVER HANDLE
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code OVE·March 31, 2015
RATCHETING SCREWDRIVER HANDLE
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code OVE·March 31, 2015
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM
FDA Adverse Event
Malfunction
·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020
UNSPECIFIED CENTRAL LINE CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·July 8, 2025
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 30, 2014
XPRT W/O PENDANT W/DARTEX
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNM·February 15, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011
InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
FDA Recall
Terminated
·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012