12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
GLUCOSE REAGENT-ENZYMATIC-COLOR 500
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NA
FDA UDI
LANCER ORTHODONTICS, INC.·00817573023356·PHASE II DUAL CURE PASTE A W/FLUORIDE (3X6g)
CRYOCARE SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Simple Science Antimicrobial Facial and Eyelid Cleanser
FDA 510(k)
FDA Unclassified
·Unknown
ENDOCARE, CRYOCARE, CRYOPROBE
FDA Adverse Event
Malfunction
·HEALTHTRONICS, INC.·Product code GEH·April 2, 2012
MINI-INFUSER RADIATION STERILIZED EXTENSION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 7, 2021
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
CONTOUR TEST STRIPS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code LFR·August 11, 2010
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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024