277 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
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
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·February 12, 2020
HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, 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
MediSense Precision QID Blood Glucose Test Strips. The product is sold in box of 50 and 100. The NDC number for the 50 count box is 57599-7400-4. The NDC number for the 100 count box is 57599-7401-5.
FDA Recall
Terminated
·AmeriSource Bergen·Product code CGA·January 30, 2004
HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
FDA Enforcement
Class I
·Terminated·Nitinol Devices and Components, Inc.·July 2, 2014
Baxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-1mL vial, 25 Pack, NDC 0641-0392-25 (NDC 0641-0392-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
FDA Enforcement
Class II
·Terminated·LIEBEL-FLARSHEIM COMPANY LLC·July 14, 2021
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-10 mL vial; 25 pack, NDC 0641-2438-45, (NDC 0641-2348-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 units/mL-30 mL vial; 25 pack, NDC 0641-2442-45 (NDC 0641-2442-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-2 mL vial, 25 pack, NDC 0641-0387-25, (NDC 0641-0387-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack , NDC 0641-0389-25, (NDC 0641-0389-21: on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-30 mL vial, 25 pack, NDC 0641-2443-45, (NDC 0641-2443-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-10 mL vial, 25 pack, NDC 0641-2436-45, (NDC 0641-2436-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 u/mL-2 mL vial, 25 pack, NDC-0641-0393-25, (NDC-0641-0393-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
FDA Enforcement
Class I
·Terminated·Nitinol Devices and Components, Inc.·July 2, 2014