13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Compressyn Staple
FDA UDI
DALLEN MEDICAL, INC.·00850815007134·
Compressyn Staple
FDA UDI
DALLEN MEDICAL, INC.·B470PEZ1309071·
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521309070·
TALOS®-C
FDA UDI
SpineArt SA·07640375236395·STERILE TALOS®-C (HA) PEEK PLANAR IBFD
K2M General Instruments
FDA UDI
VB Spine LLC·10888857561311·Box Chisel Size 8 mm
STACKED ABR FOR NAVIGATOR PRO
FDA 510(k)
FDA Class 2
·Neurology
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
FDA 510(k)
FDA Class 1
·General Hospital
MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 24, 2013
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 16, 2011
CRYSTALENS
FDA Adverse Event
Injury
·EYEONICS, INC.·Product code HQL·August 21, 2008
Vancomycin Screen Agar
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·December 30, 2015
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 1, 2018