18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PALODENT MATRICES & BITINE RINGS
FDA 510(k)
FDA Class 1
·Dental
ACUMED
FDA UDI
Acumed LLC·10806378046971·Plate Manipulator Drill Guide
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209123827·KIT, REFLEX IFAK SYSTEM - ADVANCED - BLU
AUDIO TECHNOLOGIES S:R.1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
AUTO-BAND LIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TFNA FENESTRATED HELICAL BLADE 100MM - STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·August 18, 2020
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·June 16, 1997
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYE·May 8, 2014
M2A-MAGNUM MODULAR HEAD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 23, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 11, 2007
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·December 31, 1997
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·January 7, 1998
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·December 23, 1997
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·December 23, 1997
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·August 12, 1997
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.·Product code GAG·October 9, 1997
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·December 25, 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