10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
HGB3 (1:251)
FDA 510(k)
FDA Class 2
·Hematology
BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIGITAL CLINICAL THERMOMETER MODEL V9XX
FDA 510(k)
FDA Class 2
·General Hospital
ECHELON LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 5, 2007
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015
B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022
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