23 results · 22ms · Sources: EU EUDAMED, 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