11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252657163·DELTA 1,7MM STAGGERED-HOLE MESH
JBC OPAQUE AND GLITTER
FDA 510(k)
FDA Class 2
·Dental
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 18, 2025
XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·April 26, 2018
RELIANT BALLOON
FDA Adverse Event
Death
·PARKMORE BUSINESS PARK WEST·Product code DQY·May 3, 2013
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code FSA·September 16, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 18, 2011
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 10, 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