14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KERATOR
FDA 510(k)
FDA Class 2
·Dental
8200 VALVE
FDA UDI
HANS RUDOLPH, INC.·00817136020075·8217C CO2 REB SUB W/8201 HDCRL
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE
FDA 510(k)
FDA Class 2
·Orthopedic
TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 9, 2025
X-SMART
FDA Adverse Event
Malfunction
·DENTSPLY MAILLEFER·Product code LQY·April 29, 2011
POWERED PATIENT ROTATION BED
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code IKZ·May 14, 2013
I-STAT CTNI CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code MMI·August 5, 2008
UNK - CONSTRUCTS: 2.7 MM LCP ULNA OSTEOTOMY PLATES/SCREWS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·October 11, 2024
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Enforcement
Class II
·Ongoing·Ventec Life Systems, Inc.·June 30, 2021
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025