758 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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N1
FDA 510(k)
FDA Class 2
·Dental
OptoMonitor 3
FDA UDI
Opsens Inc·07540184320127·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776406189·Siegal Nasal Retr DE 8" SS 2 Ball Prong tip 15mm
MEGA PLUS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665580405·Rod(CoCr), Ø5.5 x 120mm
Introcan Safety ® 2
FDA UDI
B. BRAUN MEDICAL INC.·04046955341979·Introcan Safety 2 - 18G x 1.25 in., PUR, Straight
Sapphire NC ULTRA Coronary Dilatation Catheter
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955982330·
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369429·PEARSON ATTACHMENT - THOMAS SMALL
SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
FDA 510(k)
FDA Class 2
·Orthopedic
HOMOCYSTEINE MICROTITER PLATE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BABY CONTROL WALL MOUNT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·April 16, 2013
AXIUM PGLA HELICAL DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·March 25, 2013
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·September 1, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 6, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 17, 2013
PROTOCO2L INSUFFLATION SYSTEM
FDA Adverse Event
Injury
·E-Z-EM, INC.·Product code FCX·February 3, 2012
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·February 23, 2012
COHERENCE THERAPIST 2.1
FDA Adverse Event
Other
·SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY·Product code IYE·March 23, 2012
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·May 21, 2012
PERMANENT PACEMAKER ELECTRODE
FDA Adverse Event
Injury
·MEDTRONIC·Product code DTB·August 12, 2023