19 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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XIVE DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518526·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518489·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518496·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518502·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518533·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518472·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033518519·
CM DRIVE ACQUA IMPLANT 5.0X13 MM
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·September 3, 2018
KILEJIAN CIRCUMCISOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 20, 2013
TENDRIL DX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
PFC KEEL TIB TRAY CEM SZ3
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 14, 2008
MITEK MILAGRO INTERFERENCE SCREW, 7 X 30MM
FDA Adverse Event
Injury
·DEPUY MITEK·Product code HWC·May 15, 2013
MITEK MILAGRO INTERFERENCE SCREW, 8 X 23MM
FDA Adverse Event
Injury
·DEPUY MITEK·Product code HWC·May 15, 2013
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
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