20 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ISO-ELASTIC CERCLAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496030256·VANITY 70 SHEER, SIZE L, SABBIA, GRADUATED COMP...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120302561·Diamond, medium grit
SCFE Screw
FDA UDI
ORTHOPEDIATRICS CORP.·00841132114698·4.0mm X 56mm SHORT THREAD CANNULATED SCREW
CAP PORP, CAP TORP
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PCCR DIGITAL IMAGING DEVICE
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 4, 2025
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 12, 2018
TRIAGE CARDIAC HS PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 22, 2019
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code MMI·May 18, 2018
TRIAGE CARDIAC PANEL KIT
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code JHX·April 18, 2018
TRIAGE CARDIAC HS PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 21, 2019
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code MMI·October 5, 2017
LEVEEN¿ SUPERSLIM¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code GEI·April 2, 2013
STENOSCOP
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·March 7, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICA INC.·Product code KWP·April 17, 2008
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·November 1, 2018
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code MMI·May 17, 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
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024