15 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
REMEL
FDA UDI
REMEL, INC.·00848838009174·Pseudomonas P Agar (slant) 20/PK
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
FDA 510(k)
FDA Class 2
·Neurology
FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRIO LX SMALL CONNECTOR
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code NBW·October 17, 2016
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·July 2, 2014
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·January 27, 2017
PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·March 19, 2013
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·September 5, 2014
HAP MODULAR TAPERLOC FEMORAL LATERALIZED STEM 9MM X 137MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 19, 2011
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code NBW·January 18, 2017
TAMPONADE URETERINE BALLOON CATHETER SET
FDA Adverse Event
Injury
·COOK UROLOGICAL·Product code KNA·October 16, 2007
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015