10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Cercon® yo ML
FDA 510(k)
FDA Class 2
·Dental
HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR
FDA 510(k)
FDA Class 2
·Orthopedic
MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W
FDA 510(k)
FDA Class 2
·Radiology
NEXGEN COMPLETE KNEE SOLUTION STEMMED NONAUGMENTABLE TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JWH·April 9, 2019
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 10, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·September 2, 2011
GYNECARE MORCELLEX TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code HET·July 22, 2013
UNKNOWN TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·July 11, 2018
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026