22 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)
FDA 510(k)
FDA Class 2
·Physical Medicine
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040044056·Bone File DE
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317302175·
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741148309·Catheter Placement Kit
intellijoint HIP (R)
FDA UDI
Intellijoint Surgical Inc·00628184008126·Femur Screw (18 mm) Sterile
MORIA
FDA UDI
MORIA SA·03700483608881·
Single Use Biliary Stent V
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170185571·
SURGITEK BREAST IMPLANT
FDA Adverse Event
MEDICAL ENGINEERING CORP.·Product code FTR·February 17, 1994
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·July 14, 2024
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·May 13, 2024
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401
FDA 510(k)
FDA Class 1
·Dental
CALCIUM
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code CJY·April 29, 2022
INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·March 12, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 17, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·February 18, 2008
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·September 26, 2012
C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·BIOMET SPINE - BROOMFIELD·Product code KWQ·November 12, 2015
C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·BIOMET SPINE - BROOMFIELD·Product code KWQ·November 12, 2015
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018