22 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
FDA 510(k)
FDA Class 2
·Neurology
ECG Module(AHA)
FDA UDI
SAMSUNG MEDISON CO., LTD.·08806167712532·
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239494·
Oticon
FDA UDI
Oticon A/S·05707131289155·H11V2 TI, MINIRITE 312 WL STG
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962104873·RAPIDCUT BLADE, 4.5MM, LONG, S
MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)
FDA 510(k)
FDA Unclassified
·Unknown
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962102886·DISPOSABLE ARTHROSCOPIC 4.5mm RAPIDCUT SHAVER B...
ONCOLOGY SALVAGE SYSTEM- TIBIAL BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·April 25, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·June 1, 2018
ARTICULEZE M 28MM 5
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ? REG. # 8010379·Product code JDI·June 6, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 6, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 5, 2008
OSS TIBIAL POLY BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·November 7, 2024
AIRVO2 HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 19, 2016
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·September 10, 2020
STEALTHSTATION S7
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·August 3, 2021
OPTIPAC 60 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·November 25, 2024
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026