10 results
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17ms
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Sources: EU EUDAMED, US FDA
MANAN NEPHROSTOMY DRAINAGE CATHETER
FDA 510(k)
FDA Unclassified
·Unknown
DeltaForm HD
FDA UDI
Merz Dental GmbH·D7091980192·DeltaForm HD upper posteriors, L, BL4 -MADE IN ...
Emprint Ablation Visualization Application
FDA 510(k)
FDA Class 2
·Radiology
HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)
FDA 510(k)
FDA Class 2
·Cardiovascular
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·February 21, 2013
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·February 1, 2011
MEGA NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·August 5, 2014
1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·January 21, 2015
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013
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