11 results
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19ms
·
Sources: EU EUDAMED, US FDA
ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE
FDA 510(k)
FDA Class 1
·Orthopedic
IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SONOTRAX ULTRASONIC POCKET DOPPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
G7 PPS LTD ACET SHELL 52E
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·January 18, 2019
ECHO(TM) BI-METRIC FULL PROXIMAL PROFILE LATERALIZED OFFSET TYPE 1 TAPER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·January 18, 2019
32MM MOD HEAD COCR STD NECK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·January 18, 2019
G7 NEUTRAL E1 LINER 32MM E
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·January 18, 2019
PFC MOD DOME PATELLA 35MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS·Product code JWH·February 4, 2013
CINCH LEAD ANCHOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·December 21, 2010
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION SYSTEMS·Product code GZB·June 18, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020