13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127291·Apex Revision Knee System-Revision Femur Size 1...
Solaris
FDA UDI
Solaris Medical Technology, Inc.·06900234100191·Philips Compatible Adult SpO2 Soft-Finger Senso...
Solaris
FDA UDI
Solaris Medical Technology, Inc.·06900234100207·Philips Compatible Pediatric SpO2 Soft-Finger S...
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
FDA 510(k)
FDA Class 2
·Neurology
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
FDA 510(k)
FDA Class 2
·General Hospital
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012
UNKNOWN AGC TIBIAL BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·May 2, 2013
PANORAMA CENTRAL STATION WITH TELEMETRY
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·August 18, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011
BACFIX ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020
1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·January 21, 2015
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024