19 results · 23ms · Sources: EU EUDAMED, US FDA

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ELECSYS PROBNP IMMUNOASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032646·Baltic Denture System BDLoad Mm6 PLSEbim6DFm D4...

ABX MICROS CRP

FDA 510(k)
FDA Class 2 ·Hematology

TERUMO 30 GAUGE HYPODERMIC NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

MARGRON STEM (K032641)

FDA Adverse Event
Injury ·PORTLAND ORTHOPAEDICS PTY LTD·Product code KWY·May 31, 2005

6.0MM TI DUAL CORE USS SCREW 30MM THRD LENGTH F/6.0MM RODS

FDA Adverse Event
Malfunction ·SYNTHES BRANDYWINE·Product code NKB·April 3, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·March 22, 2011

PRECISION XTRA / OPTIUM

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 21, 2008

SYNCHRO GUIDEWIRE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 8, 2010

SYNCHRO GUIDEWIRE

FDA Adverse Event
Death ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·August 2, 2010

SYNCHRO GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·May 27, 2010

SYNCHRO GUIDEWIRE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 15, 2010

SYNCHRO-14 STRAIGHT 200-35CM

FDA Adverse Event
Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 12, 2023

SYNCHRO-10 STRAIGHT 200CM

FDA Adverse Event
Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·October 13, 2023

SYNCHRO-14 STRAIGHT 200-35CM

FDA Adverse Event
Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·November 13, 2023

SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

FDA Enforcement
Class II ·Terminated·Unomedical As·November 9, 2016

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024