56 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LOTA SLA Dental Implant System and LOTA HA Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
ePatch 2.5, BTI
FDA UDI
BRAEMAR MANUFACTURING, LLC·B146EP2520·
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112618·BARRON CORNEAL PUNCH 7.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM
MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
FDA 510(k)
FDA Class 2
·Cardiovascular
VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL
FDA 510(k)
FDA Class 2
·Hematology
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024118799·
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024118775·
Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024118782·
HUMERIS
FDA Adverse Event
Injury
·FX SOLUTIONS·Product code HSD·August 27, 2020
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 15, 2016
CANNULATED SCREW SET 6.5/7.3 5MM DRILL BIT
FDA Adverse Event
Malfunction
·SYNTHES·Product code HTW·October 16, 2008
ATTAIN STARFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
ASPHERE M SPEC 12/14 36 +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 2, 2013
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46
FDA Recall
Open, Classified
·Linkbio Corp.·Product code HSX·March 21, 2023
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46
FDA Enforcement
Class II
·Ongoing·Linkbio Corp.·May 10, 2023
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·April 6, 2022
WHITESTAR SIGNATURE SYSTEM
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code HQC·April 14, 2021
TECNIS IOL
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code MFK·April 22, 2021
TECNIS IOL
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code POE·April 22, 2021