16 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SUMMIT OCT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00845694000468·1.2mm x 3mm Screw
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7403041203·12mm x 30mm Portal Tube
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112030·Tap, 5.5 mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694028851·1.2mm x 3mm Screw, Sterile
OsteoMed
FDA UDI
OSTEOMED LLC·00845694054379·1.2 x 3mm Screw Sterile Qty 10
OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT
FDA 510(k)
FDA Class 2
·Radiology
ABX MICROS 60 HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
ADVIA CENTAUR XP AFP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOJ·June 4, 2019
ADVIA CENTAUR XP AFP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOJ·June 4, 2019
S8 AUTOSET VANTAGE -AMERICAS
FDA Adverse Event
Malfunction
·RESMED LTD.·Product code BZD·April 2, 2013
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 29, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code LFR·May 9, 2008
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 14, 2012
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018