15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PMT BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
VEO Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996187992·VEO,BULLETED TRIAL,12 DEG,17X13
VEO Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996164979·VEO,TRIAL,17X13X12 DEGREE
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
LIPCOLLECTOR II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STAT PROFILE PHOX PLUS C ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MICRONY II SR PLUS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 13, 2014
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Malfunction
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWY·May 21, 2013
LAGUNA PEDICLE SCREW SYSTEM
FDA Adverse Event
Malfunction
·PHYGEN, LLC.·Product code MNI·May 17, 2011
D902 LILLIPUT ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022
ULTRAXX NEPHROSTOMY BALLOON AND SET
FDA Adverse Event
Malfunction
·COOK INC·Product code LJE·August 8, 2024
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026