12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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T2 FEMORAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014609928·MIDMARK 5" SOFTCARE
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VASOTRAC APM205A
FDA 510(k)
FDA Class 2
·Cardiovascular
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·NULL·Product code FPA·February 4, 2022
EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·September 9, 2011
SMARTSET MV 40G - EO
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LOD·October 18, 2019
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·April 26, 2013
LADARVISION
FDA Adverse Event
Injury
·ALCON - ORLANDO TECHNOLOGY CTR·Product code LZS·June 19, 2008
HARMONIC ACE
FDA Adverse Event
Malfunction
·ASCENT HEALTHCARE SOLUTIONS·Product code LFL·May 3, 2011
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012