18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OPTIBOND FL
FDA 510(k)
FDA Class 2
·Dental
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496031444·ANTI TROMBO, SIZE M, NATUR, GRADUATED COMPRESSI...
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746150272·1 PAT SETUP MINI MS 022 UPPER 5X5 W/HK 3,4,5 S...
HANSON MEDICAL, INC.
FDA registration
HANSON MEDICAL, INC.·9 products·🇺🇸 United States
STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103
FDA 510(k)
FDA Class 2
·General Hospital
ANSPACH EMAX DRILL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
16CM MIN. INVASIVE ATTACHMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·March 29, 2013
NOVATION HIP COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code LPH·November 10, 2025
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 2, 2013
SENSOR, MMT-7002C, 10PK, GLUCOSE, BSA, 17L
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·March 14, 2011
ACRYSOF
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD.·Product code HQL·April 18, 2008
EMAX 2 MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 6, 2015
8CM ANGLE ATTACHMENT, BLACK, MAX
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 9, 2014
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
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
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020