16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Polaris Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ION HEALTH USB INSTA-SCAN THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Malfunction
·LDR MEDICAL·Product code OVE·February 4, 2020
ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X17MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code OVE·April 13, 2020
ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H5MM 14X15.5MM
FDA Adverse Event
Malfunction
·LDR MEDICAL·Product code OVE·August 6, 2020
LENSX LASER SYSTEM
FDA Adverse Event
Injury
·ALCON LENSX INC.·Product code OOE·October 6, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code OJX·June 7, 2013
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code OVE·August 24, 2021
SPACER, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MEDICAL·Product code ODP·August 23, 2019
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 15, 2019
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code OVE·September 21, 2021
ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X15,5MM
FDA Adverse Event
Malfunction
·LDR MÉDICAL·Product code OVE·August 17, 2022
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023