18 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN
FDA 510(k)
FDA Class 2
·Microbiology
Safco air/water syringe tips
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310201623·Safco air/water syringe tip A-dec 5pk
Megadyne
FDA UDI
MEGADYNE MEDICAL PRODUCTS, INC.·10614559103340·Front Display PCB Assembly, Original Faceplate,...
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717101281·Burs FGSL 702, Pkg/5
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450854488·
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
FDA 510(k)
FDA Class 2
·Cardiovascular
METRISCAN BONE DENSITY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·September 21, 2020
SMR GLENOID BASEPLATE SMALL-R
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code KWS·July 2, 2021
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·CARROLL HEALTHCARE·Product code FNL·March 25, 2013
NI
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·March 7, 2011
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·October 6, 2021
STEALTHSTATION S7
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·October 4, 2021
ONYX AVM
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·September 19, 2023
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018