11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MILTEX MEMBRANE TACK KIT
FDA 510(k)
FDA Class 2
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450316078·
LIQUISPX LIQUID LIPID CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CALCIUM
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES (IRVING IA/CC)·Product code CJY·September 1, 2020
DIDECO COMPACTFLO EVOLUTION OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 15, 2016
DISTAL LATERAL FIBULA PLATE, 3 HOLE
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code KTT·May 3, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 16, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·May 5, 2011
Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·March 20, 2013
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