30 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PREMIO 10 MOXA
FDA 510(k)
FDA Class 2
·Physical Medicine
Invivo
FDA UDI
Philips Ds North America LLC·00884838080898·0.7T HEAD T/R PA COIL
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780374961·Integra® Jarit® Metzenbaum-Nelson Scissors, 9-1...
Needle Guide
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436102893·Sterile needle guides (.5cm, 1cm, 1.5cm, 2cm de...
JARIT SURGICAL SCISSORS
FDA Adverse Event
Injury
·JARIT/INTEGRA LIFESCIENCES CORP.·Product code LRW·September 7, 2017
EXHALE RF PROBE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
GE SYSTEM FIVE
FDA 510(k)
FDA Class 2
·Radiology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 26, 2019
CARB-EDGE METZ SCS 9 CVD
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code DWS·October 22, 2017
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 24, 2011
AMARA VIEW MASK
FDA Adverse Event
Injury
·PHILIPS NORTH AMERICA LLC·Product code BZD·December 8, 2022
ONYX PV
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·April 8, 2017
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·April 8, 2017
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·April 8, 2017
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025
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