14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TruForm
FDA UDI
Rmo, Inc.·00885797099679·MAN MOLAR BDS PEDO ASST 100
TensCare
FDA UDI
TENSCARE LIMITED·05033435135776·The Nouri Digital Electric Breast Pump is a pow...
Rotating Shaft- Tischler Tip - Up
FDA UDI
MEDGYN PRODUCTS, INC.·M803030147·Rotating Shaft- Tischler Tip - Up
CTC DVT-1 CALF GARMENT, MODEL DVT-1
FDA 510(k)
FDA Class 2
·Cardiovascular
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ECHELON*FLEX60 ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 2, 2013
CAPIOX FX OXYGENATOR
FDA Adverse Event
TERUMO CORP·Product code DTZ·March 16, 2011
ONE TOUCH PROFILE METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·April 15, 2008
AQUAPAK 340 SW, 340ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 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