9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HISPEED QX/I CT SCANNER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DeltaForm HD
FDA UDI
Merz Dental GmbH·D7091980176·DeltaForm HD upper posteriors, S, BL2 -MADE IN ...
SeaSpine NewPort Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·February 21, 2013
NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·February 1, 2011
TRICUT® ANGLE-TIP BRONCHIAL BLADE
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code EQJ·August 5, 2014
Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k K980196. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Pediatric Bone Marrow Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009
Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS1833(A Basic Pack, part number PSS1848(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017