42 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRANSTEK WRIST BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM
FDA 510(k)
FDA Class 2
·Cardiovascular
SENSA-CUFF, MODELS INFANT, CHILD, ADULT
FDA 510(k)
FDA Class 2
·Cardiovascular
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·Product code BZE·September 10, 2020
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·Product code BZE·December 4, 2020
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·May 31, 2019
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·March 19, 2023
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·February 21, 2023
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·May 4, 2023
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·Product code BZE·June 25, 2021
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·September 6, 2017
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·Product code BZE·February 25, 2021
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·Product code BZE·March 18, 2021
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·Product code BZE·February 26, 2020
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·January 12, 2020
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·August 28, 2019
ADULT VENTILATOR DUAL HEATED CIRCUIT KIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·November 13, 2019
- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289 - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592 Orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
OBTAPE TRANSOBTURATOR SLING
FDA Adverse Event
Injury
·MENTOR WORLDWIDE LLC·Product code FTL·May 8, 2013
CS300
FDA Adverse Event
Malfunction
·DATASCOPE CORP·Product code DSP·September 22, 2014