12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
FDA 510(k)
FDA Class 2
·Cardiovascular
INTELLIVUE MX500 PATIENT MONITOR
FDA Adverse Event
Death
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·December 4, 2023
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G2231318720·PEDIATRIC ETHMOID FORCEP STRAIGHT 3.5MM CUPS
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
FDA 510(k)
FDA Class 2
·Hematology
ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]
FDA 510(k)
FDA Class 2
·Radiology
MEDTRONIC MINIMED 670G
FDA Adverse Event
Injury
·MEDTRONIC·Product code CGA·December 6, 2016
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 1, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 16, 2011
HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code NLQ·May 6, 2022
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020