16 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONDUIT LLIF Straight Inserters
FDA 510(k)
FDA Class 2
·Orthopedic
LCP
FDA UDI
Synthes GmbH·10886982158116·3.5MM LCP PLATE 18 HOLES 241MM
AQUEOUS ACRYLIC DISPERSION 28% W/W
FDA 510(k)
FDA Class 2
·Dental
WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PINNACLE SECTOR II CUP 60MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 13, 2013
PINN CAN BONE SCREW 6.5MMX30MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·November 13, 2013
PINN CAN BONE SCREW 6.5MMX25MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NDJ·November 13, 2013
CORAIL2 NON COL HO SIZE 12
FDA Adverse Event
Injury
·DEPUY FRANCE SAS - 3003895575·Product code KWA·November 13, 2013
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 5, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
BD MICRO-FINE¿+ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 14, 2022
12/14 ARTICUL 40MM M SPEC+5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 8, 2013
PINNACLE MTL INS NEUT40IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 8, 2013
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026