17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
FDA 510(k)
FDA Class 2
·Anesthesiology
artegral life
FDA UDI
Merz Dental GmbH·D7091993010·anteriors; shade A1; mould BIL
SCOTT'S SELECT NANO SYRINGE 4.5 Gm (OPAQ)
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77819930100·Nanohybrid Composite contains a new ytterbium f...
Bioseal Inc.
FDA UDI
BIOSEAL·00630094199306·Double Mouth Guard Junior
Child Richardson Blade
FDA UDI
KOROS U.S.A., INC.·10840199542779·Child Richardson Blade 3/4 x 1"
Galaxy Fixation System
FDA UDI
ORTHOFIX SRL·18033509859595·LARGE CLAMP STERILE
Bipolar electrode
FDA UDI
SOPRO-COMEG GmbH·04059082014623·
Liebel-Flarsheim IBP Transfer Set
FDA 510(k)
FDA Class 2
·General Hospital
MACH LED MC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 19, 2016
M2A TPR HI CARBON 37/28MM LNR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 30, 2018
Proteus XR/a (SlOK : K993090)
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code KPR·August 9, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·April 9, 2015
TAXUS® LIBERTÉ®
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 7, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·February 7, 2011
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC SINGAPORE OPERATIONS·Product code NVN·August 8, 2014
Proteus XR/a (SlOK : K993090)
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·October 2, 2019