19 results · 29ms · Sources: EU EUDAMED, 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