75 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
FDA 510(k)
FDA Class 2
·Anesthesiology
Pope
FDA UDI
MEDTRONIC XOMED, INC.·00681490031110·VENT TUBE 1040014 10PK POPE GROMMET 1.14
Leksell Vantage Stereotactic System
FDA UDI
Elekta Solutions AB·07340201501399·LEKSELL VANTAGE CT FIDUCIAL BOX
Pope
FDA UDI
MEDTRONIC XOMED, INC.·00763000039202·VENT TUBE 1040014 10PK POPE GROMMET 1.14
23GA Curved Laser Probe, SMA906
FDA UDI
Peregrine Surgical, Llc·00632307001789·23GA Curved Laser Probe, SMA906
n/a
FDA UDI
Ortho Development Corporation·00822409073795·10/12 Distal Reamer 14mm
Ormco
FDA UDI
ORMCO CORPORATION·00889989024777·BONDABLE LINGUAL RETAINER CUSPID 4
Trulink
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522126307·CO2 NASAL CANNULA W/O2, ADULT
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710820400140·Zadik Calcaneal Guide, 40mm x 14°
BARCOMED 5MP1H
FDA 510(k)
FDA Class 2
·Radiology
MD 30 COMPACT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·November 23, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code NBW·September 28, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·December 13, 2016
PRECISION XTRA
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·October 26, 2016
RADICAL
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·April 16, 2015
HARMONIC ACE
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY·Product code LFL·April 3, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP·Product code LZG·March 25, 2011