15 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ICT
FDA 510(k)
FDA Class 2
·Radiology
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925013124·SCHUKNECHT INSTRUMENT CASE FOR 12 INSTRUMENTS
NUPRO®
FDA UDI
Dentsply Professional·D0031302241·NUPRO® 5% Sodium Fluoride White Varnish, Patien...
N/A
FDA UDI
Tyber Medical, LLC·M695M1302240·
HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING
FDA 510(k)
FDA Class 2
·General Hospital
ESTECH COBRA BIPOLSR II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Realstar Surgical
FDA UDI
REAL STAR SURGICAL INSTRUMENTS·00850071684025·Weisman Speculum 90° (Left Open), Medium
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·May 22, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 22, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·April 30, 2024
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 12, 2013
ULTRA 8 IAB: 8FR 30CC
FDA Adverse Event
Injury
·ARROW INTERNATIONAL LLC·Product code DSP·July 10, 2023
Artis zee multi-purpose, Model Number 10094139
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015