52 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INZONE DETACHMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Unity Total Knee System
FDA UDI
CORIN LTD·05056139249198·UNITY KNEE™ PS-C INSERT - Size 8 x 16mm
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743755·ACHIMED ACHILLES SUPP SAND VI
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321208160·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319704073·Graefe Eye Tissue Forceps 2-3/4" (7cm), straigh...
WeightRight®
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734020463·Tungsten-Filled Maloney Esophageal Dilator, 16 ...
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PK SUPERPULSE SYSEM GENERATOR MODEL 744000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2013
ANGEL WING 23G BCS W/ LUER ADPTR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code GJE·July 28, 2014
UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 11, 2011
LACRIFAST
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code OKS·December 25, 2016
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
LACRIFAST
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code OKS·December 25, 2016
LACRIFAST
FDA Adverse Event
Malfunction
·KANEKA CORP.·Product code OKS·August 19, 2014
LACRIFAST
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code OKS·January 13, 2017
LACRIFAST
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code OKS·December 25, 2016
LACRIFAST
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code OKS·December 25, 2016
LACRIFAST
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code OKS·December 25, 2016
LACRIFAST
FDA Adverse Event
Malfunction
·KANEKA CORPORATION·Product code OKS·January 5, 2017