510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Osprey Medical, Inc.

Eden Prairie, MN, US

Osprey Medical, Inc. appears in FDA device records in Eden Prairie, MN. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
15
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 15 510(k) clearances for Osprey Medical, Inc. between 2013 and 2019. The busiest year on record is 2015, with 4. The most recent is 2019, with 1.

Clearances by year, as a table
510(k) clearance decisions for Osprey Medical, Inc., by decision year
YearClearances
20131
20142
20154
20162
20173
20182
20191
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction SystemDXTSubstantially Equivalent
K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction SystemDXTSubstantially Equivalent
K181936DyeVert PLUS EZ Contrast Reduction SystemDXTSubstantially Equivalent
K171698Smart SyringeDXTSubstantially Equivalent
K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemDXTSubstantially Equivalent
K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemDXTSubstantially Equivalent
K161505DyeVert NG Contrast Modulation SystemDXTSubstantially Equivalent
K153141DyeVert Contrast Modulation SystemDXTSubstantially Equivalent
K151300AVERT Contrast Modulation SystemDXTSubstantially Equivalent
K151746Dyevert Contrast Modulation SystemDXTSubstantially Equivalent
K152218AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation SystemDXTSubstantially Equivalent
K150485AVERT Contrast Modulation SystemDXTSubstantially Equivalent
K142081CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGESDXTSubstantially Equivalent
K140425CONTRAST MODULATION SYSTEMDXTSubstantially Equivalent
K131478CONTRAST CONSERVATION SYSTEMDXTSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain