17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813841·GENUMEDI PRO SILVER SIZE IV
TASMIN R 12°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844014950·The basic shape of the TASMIN R devices is a ho...
Vatech Clismile
FDA UDI
Rayence Co., Ltd.·08800018601303·This product is an orthodontic bracket and is u...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450666456·
Critical Cover
FDA UDI
Alpha Pro Tech, Inc.·10817583021646·Frock, GenPro, White, Raglan Sleeve, Elastic Wr...
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071152185·12F x 1.2cm MiniSPC Low Profile Suprapubic Cath...
SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS
FDA 510(k)
FDA Class 2
·General Hospital
ENDOCERVICAL BLOCK NEEDLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·March 5, 2019
ARTHREX ANGEL SYSTEM WITH ASPIRATION KIT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code ORG·May 1, 2019
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
UNKNOWN·Product code ITJ·May 20, 2013
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 1, 2011
KENTROX SL-S 65/16 STEROID
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO.·Product code LWS·August 15, 2008
ACCESS ACCUTNI REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·September 15, 2016
THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code GWO·April 16, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012