23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SUPRASPERM SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Premier Elevator
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783004250·ELEVATOR 44 CRYER
PERMITE
FDA UDI
SDI LIMITED·09336472000592·PERMITE 3SP SLOW 50
PERMITE
FDA UDI
SDI LIMITED·DO3640034042·
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159003192·Mayo-Hegar Needle Holder Diamond Dust™ Jaw
Spacelabs Healthcare
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522124792·4 ELECTRODE EVO RECORDER, PACKED, ITALIAN
WVSM Wireless Vital Signs Monitor
FDA UDI
ATHENA GTX, INC.·B3945000034040·Wireless Patient Monitor
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·January 3, 2025
GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PC ECG 1200
FDA 510(k)
FDA Class 2
·Cardiovascular
INSET
FDA Adverse Event
Malfunction
·Product code FPA·May 17, 2024
INSET
FDA Adverse Event
Malfunction
·Product code FPA·May 17, 2024
INSET I 60/9 GREY T-CAP
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 7, 2024
INSET I 60/9 GREY T-CAP
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 7, 2024
SYRINGE 2ML EMERALD BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·August 14, 2020
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·February 13, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 1, 2011
ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·February 21, 2008
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·February 18, 2025
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014