14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE
FDA 510(k)
FDA Class 2
·Cardiovascular
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788021694·Wiley-Spinal™ Flexible Needle
SCOTT'S SELECT MICROHYBRID COMPULES 15-.3 Gm (C3)
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77819923401·Microhybrid composite restorative material. Lig...
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111086·INSTRUMENT CASE LARGE ALUMINUM
PICCOLO BASIC METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·October 22, 2020
PICCOLO COMPREHENSIVE METABOLIC PANEL
FDA Adverse Event
Malfunction
·ABAXIS, INC.·Product code CGX·November 3, 2020
CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OptoMonitor
FDA 510(k)
FDA Class 2
·Cardiovascular
EARIGATOR
FDA Adverse Event
Malfunction
·SURYA TECHNOLOGIES INTERNATIONAL·Product code JYH·January 4, 2001
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 7, 2013
CAPSURE SENSE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·August 8, 2014
NAIL, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDS·July 25, 2016
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020