11 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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STERILE, DISP DOME, INDIVID. PKG.
FDA 510(k)
FDA Class 2
·Cardiovascular
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668117620·Thorpe Corneal Forceps, 2x3 Teeth, .12mm
ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VIEWFLEX PLUS ICE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TOTAL ASR ACET IMP SIZE 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 8, 2014
REMSTAR AUTO M-SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·October 17, 2012
PINNACLE SECTOR II CUP 54MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·August 11, 2010
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·July 1, 2020
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024