16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·December 26, 2012
Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·August 8, 2012
Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·August 8, 2012
Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·August 8, 2012
Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·August 8, 2012
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·August 8, 2012
Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·August 8, 2012
Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·August 8, 2012
Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·August 8, 2012
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·August 8, 2012
Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·August 8, 2012
Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The Mixing Pen is used to dispense a solution from a standard 3 mL size cartridge into a second fluid container.
FDA Enforcement
Class II
·Terminated·Valeant Pharmacueticals International·May 25, 2016
Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, and G1806. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·February 27, 2019
Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325, G1412, G1481, G1509, G1548, G1581, G1586, G1602, G1627, G1632, G1634, G1671, G1675, G1716, G1724, G1773, and G1807. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·February 27, 2019
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·November 13, 2024
NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar ridge -filling of infrabony periodontal defects -filling of defects after root resection, apicoectomy and cystectomy -filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of maxillary sinus floor -filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) -Filling of pre-implant defects in conjunction with products intended for Guided Bone Regeneration
FDA Enforcement
Class II
·Terminated·Collagen Matrix Inc·March 23, 2016