23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Paltop Conical Implant System
FDA 510(k)
FDA Class 2
·Dental
MaXcess
FDA UDI
Nuvasive, Inc.·00887517191281·MaXcess Attachment, 4th Blade
OsteoMed
FDA UDI
OSTEOMED LLC·00845694007450·Fast Flap Delivery System Organizer Tray
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702934670·ELVAREX 4/THIGH HIGH/SLANT-CLOSED TOE/DOTTED S...
2.0 TPLO SS polyaxial locking plate right
FDA UDI
mahe medical gmbh·EMAH15062202000·2.0 TPLO SS polyaxial locking plate
right
1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock
FDA 510(k)
FDA Class 2
·General Hospital
PLAYTEX DEODORANT TAMPONS, MODEL 34802
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Coselgi
FDA UDI
Widex A/S·05706069529630·Audio Control, Coselgi (Black )
VERSE CORRECTION KEY
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·December 4, 2020
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 3, 2014
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·August 23, 2011
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
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
ENDO CLIP III
FDA Adverse Event
Malfunction
·DAVIS & GECK CARIBE LTD·Product code FZP·September 8, 2025
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·April 30, 2020
RESTYLANE DEFYNE
FDA Adverse Event
Injury
·Q-MED·Product code LMH·June 15, 2023
FREESTYLE LIBRE 2
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code QLG·May 14, 2026
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2016
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 Enforcement
Class II
·Terminated·CooperSurgical, Inc.·August 25, 2021
TEBBETTS FIBEROPTIC SS RETR 9CMX30MM
FDA Adverse Event
Injury
·CAREFUSION·Product code FDG·December 22, 2011