19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOPSY MEDIUM, MODEL REF 1062
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BioQuick®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609831·BioQuick-Brackets Roth .018" 200 Brackets 3-5 w...
PLLA PIN
FDA 510(k)
FDA Class 2
·Orthopedic
CERAMIX PORCELAIN SYSTEM
FDA 510(k)
FDA Class 2
·Dental
KYPHON HV-R BONE CEMENT
FDA Adverse Event
Injury
·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 25, 2017
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·April 7, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 19, 2020
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 4, 2019
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Injury
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 17, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·December 17, 2018
KYPHX® HV-R¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 7, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 12, 2017
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 9, 2020
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 26, 2013
MICROPLEX 10-SYSTEM COIL (MCS)
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code HCG·June 12, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 18, 2011
SUPER MULTIVAC 50 ICW
FDA Adverse Event
Injury
·ARTHROCARE CORP.·Product code GEI·August 13, 2021
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024