10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OSTEONICS PS HEAD AND NECK HIP STEM SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
Stern IC Acid Etched Implant 3.3mm RN, 1.8mm, 10mm,Biomain, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549109881·The Stern IC Dental Implant device is a root-fo...
THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F
FDA 510(k)
FDA Class 2
·General Hospital
SKIN BARRIER FILM
FDA 510(k)
FDA Class 1
·General Hospital
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·CODMAN AND SHURTLEFF, INC·Product code HCG·June 30, 2014
PK DISSECTING FORCEPS
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·January 8, 2013
COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 18, 2010
Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part number AMS2501(A Lumbar Laminectomy Pack, part number AMS2501(B
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
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