FDA.reportPublic FDA data

OSPREY MEDICAL, INC

Matched from indexed company URL: Osprey Medical Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103687623010368762OSPREY MEDICAL, INC1N2020-04-255600 Rowland Rd Suite 250 Minnetonka MN US 55343

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00815241020416DYETECT™ Contrast Monitoring Disposable Kit - DyeTect Contrast Monitoring Disposable Kit9529558247vfabano@ospreymed.com
00815241020430DYETECT™ Contrast Monitoring Disposable Kit - DyeTect Contrast Monitoring Disposable Kit9529558247vfabano@ospreymed.com
00815241020485SMART SYRINGE - Smart Syringe to be used with DyeVert Plus or the CMSW Disposable Kit9529558247vfabano@ospreymed.com
00815241020492SMART SYRINGE - Smart Syringe to be used with DyeVert Plus or the CMSW Disposable Kit9529558247vfabano@ospreymed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1621132061851978K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction SystemDXT2019-10-17
1621131385514190K181936DyeVert PLUS EZ Contrast Reduction SystemDXT2018-10-25
1621131330152549K171698Smart SyringeDXT2017-07-07
1621131456339945K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemDXT2017-03-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXT42019-10-17

PMN#

GUDID#