22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
FDA 510(k)
FDA Class 2
·Hematology
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702384369·ELVAREX 2/MID THIGH HIGH/SLANT-CLOSED TOE/DOTTE...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702288933·Elvarex 3/Thigh High/Open Toe/Top Comfort-Witho...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702395631·Elvarex Forte 3/Knee High/Slant-Closed Toe-Elep...
JOBST Confidence
FDA UDI
BSN-Jobst GmbH·04059993471836·CONFIDENCE 1/THIGH HIGH/SLANT-OPEN TOE-FOOT FUN...
JOBST Confidence
FDA UDI
BSN-Jobst GmbH·04059993442072·CONFIDENCE 2/THIGH HIGH/SLANT-OPEN TOE-FOOT FUN...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702418675·ELVAREX 2/CHAP STYLE/CLOSED TOE/SLIP FORM WITH ...
JOBST Confidence
FDA UDI
BSN-Jobst GmbH·04059993452095·CONFIDENCE 3/THIGH HIGH/SLANT-OPEN TOE-FOOT FUN...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702417999·Elvarex 3/Knee High/Profile-Slant-Open Toe-Elep...
BTP-1000S
FDA UDI
BRAEMAR MANUFACTURING, LLC·B146C6S0·MCOT Holter
CRP HS TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
SYNERGY FLOW
FDA 510(k)
FDA Class 2
·Dental
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·May 10, 2018
TAPERLOC POR FMRL 15X150
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·April 25, 2019
SONICFILL COMPOSITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EBF·April 17, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·April 19, 2011
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·June 19, 2008
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·February 10, 2025
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016