104 results
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36ms
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Sources: EU EUDAMED, US FDA
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODIFIED J&C LOOP POST. CHAMBER INTRAOCULAR LENS
Gauthier Biomedical
FDA UDI
GAUTHIER BIOMEDICAL, INC.·00858325005374·G10 LARGE INLINE RATCHETING HANDLE, SMALL HUDSO...
Barricade Coil System
FDA UDI
BALT USA LLC·00818053020384·Barricade Coil System (BCS) is intended for the...
ACUMED
FDA UDI
Acumed LLC·10806378053436·Polarus® 3 X-Ray Template
Insight Discovery EMG
FDA UDI
SRS Medical Systems, Inc.·00890477000098·
BPX
FDA UDI
STRYKER CORPORATION·07613327657814·Reciprocating Saw
Stryker F1
FDA UDI
STRYKER CORPORATION·07613327072013·Reciprocating Saw
XBraid S
FDA UDI
RIVERPOINT MEDICAL, LLC·00810020082388·Suture
Palladian™
FDA UDI
NEUROSTRUCTURES, INC·00841508106913·Set Screw Starter Driver
FORTRESS 755FS PEDIATRIC WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·ASSURE Wearable Cardioverter Defibrillator (WCD) System
ON-X PROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·ON-X LIFE TEHCNOLOGIES, INC.·Product code DYE·January 14, 2016
ON-X MITRAL PROSTHETIC HEART VALVE
FDA Adverse Event
Other
·ON-X LIFE TECHNOLOGIES, INC.·Product code LWQ·July 14, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 27, 2014
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FMF·November 8, 2010
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 26, 2012
ONX AORTIC ANATOMIC EXT 27/29
FDA Adverse Event
Injury
·ONX LIFE TECHNOLOGIES, INC.·Product code LWQ·March 14, 2017
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·ON-X PROSTHETIC HEART VALVE
Wearable Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·ASSURE Wearable Cardioverter Defibrillator (WCD) System