15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EndoWave Infusion System
FDA 510(k)
FDA Class 2
·Cardiovascular
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606026·SKYTRON 6700/6100 SOFTCARE 2" SOFT CARE FOAM W/...
Mapleson Anesthesia Breathing Circuit
FDA UDI
MERCURY ENTERPRISES, INC.·10641043803929·
RESPONSE 2000 HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
ATHENA REMOTE CONTROLLED RF SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
REBOUND HRD
FDA Adverse Event
Malfunction
·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011
FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·April 26, 2013
SWIFT-LOCK ANCHOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 22, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·July 24, 2008
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023
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
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015