12 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HEALIX ADVANCE KNOTLESS BR ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
A.S.A.P.® All Surface Access Polishers Assorted Starter Pack
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172012911·Dental polishing point
A.S.A.P.® All Surface Access Polishers Assorted Starter Pack
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883003456·Dental polishing point
FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130
FDA 510(k)
FDA Class 2
·Anesthesiology
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·October 25, 2024
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·May 24, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 30, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 16, 2011
AMISTEM H SIZE 2 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 8, 2013
BD PHASEAL PROTECTOR P50J
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·July 7, 2023
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