10 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3 Series Phototherapy Unit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
FDA 510(k)
FDA Class 1
·General Hospital
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·April 4, 2018
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NTE·July 7, 2011
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code NVN·June 8, 2013
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/12 MM LEFT
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·March 8, 2017
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023