12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
Biomet Headless Compression and Twist-off Screws
FDA 510(k)
FDA Class 2
·Orthopedic
PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004
FDA 510(k)
FDA Class 2
·Dental
BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·March 27, 2019
T7 DRIVER CANN AO
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code LXH·July 14, 2016
COULTER ACT 2 DIFF ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·September 10, 2011
ARTICUL/EZE BALL 28 + 1.5 GR
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code JDI·November 20, 2008
SELOX JT 45
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·July 23, 2013
BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 16, 2019
CHLORAPREP ONE-STEP HI-LITE ORANGE
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code KXG·December 3, 2020
BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·March 8, 2019
PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014