19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ArtiSential Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Mepilex® Up
FDA UDI
Mölnlycke Health Care AB·07333350341374·Mepilex Up 20x50cm
Oticon
FDA UDI
Oticon A/S·05707131376435·OPN PLAY 1, MINIRITE T 312 2.4G C045
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704514353·
K-Systems
FDA UDI
RESEARCH INSTRUMENTS LIMITED·05060554120291·Assisted Reproduction Accessories
PROFYLE
FDA UDI
Stryker GmbH·04546540258878·Screwdriver
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482001066·Symmetry® Case, Gouge & Osteotome, Dimensions 9...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702827262·ELVAREX 3/KNEE HIGH/SLANT-OPEN TOE-ELEPHANTIASI...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702421217·ELVAREX 3/THIGH HIGH/PROFILE-CLOSED TOE/DOTTED ...
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295087861·HEAD REMOVER
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295087878·ISSUE SPARING SOLUTIONS MODULAR HEAD BALL REMOVER
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101276·R CR Cemented Femoral Component Sz 5
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
FDA 510(k)
FDA Class 2
·Radiology
NEO PS KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 22, 2021
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014
VCARE VAGINAL-CERVICAL RETRACTOR-ELEVATOR
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code LKF·August 16, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023