25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dental porcelain powder
FDA 510(k)
FDA Class 2
·Dental
NA
FDA UDI
Medos International Sàrl·10886705026258·TCK1 HD Camera Head, C-Mount
TOTAL MANDIBULAR SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036062415·
G185
FDA UDI
RESEARCH INSTRUMENTS LIMITED·05060554120086·G185 Incubator for assisted reproduction
G185
FDA UDI
RESEARCH INSTRUMENTS LIMITED·05060554120093·Incubator for Assisted reproduction
MUCOTROL CONCENTRATED ORAL GEL WAFER
FDA 510(k)
FDA Unclassified
·Unknown
SONON Ultrasound Imaging System, Model: SONON 500L
FDA 510(k)
FDA Class 2
·Radiology
ATLAS II PLUS HF CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 10, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 11, 2014
GYNECARE TVT OBTURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
TCK1 HD CAMERA HEAD
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code FWF·March 28, 2019
TCK1 HD CAMERA HEAD
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL·Product code FWF·July 11, 2019
Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code FMZ·June 30, 2021
TCK1 HD CAMERA HEAD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code FWF·January 29, 2019
ARCTIC SUN® 5000
FDA Adverse Event
Malfunction
·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·September 18, 2024
TCK1 HD CAMERA HEAD
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL·Product code FWF·November 29, 2018
TCK1 HD CAMERA HEAD
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL·Product code FWF·November 30, 2018
TCK1 HD CAMERA HEAD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code FWF·November 29, 2018
TCK1 HD CAMERA HEAD
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code FWF·May 9, 2019
TCK1 HD CAMERA HEAD
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL·Product code FWF·March 11, 2019