45 results
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9ms
·
Sources: EU EUDAMED, US FDA
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
FDA Enforcement
Class II
·Terminated·FSC Laboratories, Inc·June 22, 2016
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
FDA Enforcement
Class II
·Terminated·App Pharmaceuticals Llc·June 27, 2012
Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
FDA Enforcement
Class II
·Terminated·Rainbow Specialty & Health Products·December 30, 2015
Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
FDA Enforcement
Class II
·Terminated·Rainbow Specialty & Health Products·December 30, 2015
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
FDA Enforcement
Class II
·Terminated·Fresenius Kabi USA, LLC·February 4, 2015
VAPORIZER VICKS 1.5GAL Item Number: 2354942
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
FREESTYLE LANCETS 28G 100CT Item Number:2975670
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
FDA Enforcement
Class II
·Ongoing·Cardinal Health Inc.·June 30, 2021
Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·February 12, 2020