14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V30 system, V-Form Handpiece BC Medium applicator
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bi-Metric® Revision Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868261527·
BI-METRIC REVISION HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304003514·
BI-METRIC(R) HEAD/NECK PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304307551·
COTTLE NASAL SPECULUM
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896090422·COTTLE NASAL SPECULUM MODIFIED THIN WIDE BLADES
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 13, 2021
BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
FDA 510(k)
FDA Class 2
·General Hospital
BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·April 25, 2022
PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·June 6, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·September 9, 2008
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 10, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021