16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMYLASE EPS REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ComfortGel Blue
FDA UDI
Respironics, Inc.·00606959001572·ComfortGel Blue Nasal Mask with Headgear, Large...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690774·Titanium Anatomic Angulated Concave Abutment In...
PERSONA® Persona SoluTion™
FDA UDI
Zimmer, Inc.·00889024231788·
PERSONA® Persona SoluTion™
FDA UDI
Zimmer, Inc.·00889024231771·
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
FDA 510(k)
FDA Class 2
·Hematology
ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY
FDA 510(k)
FDA Class 2
·Radiology
COPPERHEAD CERVICAL INTERBODY CAGE
FDA Adverse Event
Injury
·EMINENT SPINE·Product code ODP·January 8, 2016
SEE H10 NARRATIVE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·September 11, 2017
GRAFTYS BCP (510K NUMBER: K073064)
FDA Adverse Event
Injury
·GRAFTYS·Product code MQV·July 11, 2013
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS LLC·Product code LZG·May 8, 2019
UNKNOWN LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015
8.5MM MEDULLARY REAMER HEAD
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·April 22, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·July 3, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 26, 2011