11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dymaxeon Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111010903·FEILCHENFELD SPLINTER FCP 3"
NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED
FDA 510(k)
FDA Class 2
·General Hospital
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2014
LOCKSCR Ø3.5 SELF-TAP L34 SST
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·June 27, 2013
B. BRAUN MEDICAL INC
FDA Adverse Event
Injury
·B. BRAUN MEDICAL INC.·Product code NGT·February 1, 2008
ARCOS LATERAL TROCH BOLT 24MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 28, 2017
ARCOS LATERAL TROCH BOLT 28MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 28, 2017
ARCOS TROCH BUTTON 25MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 13, 2018
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016