17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AccelFix Lumbar Interbody Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101070·WALTON CONJUNCTIVA RETRACTOR
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319741832·Spratt (Brun) Bone Curette 6-1/2" (16.3cm), siz...
PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...
FDA 510(k)
FDA Class 2
·Orthopedic
RADIFOCUS OPTITORQUE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022
INNOVA 2100
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code MQB·October 6, 2008
PACS SERVER
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code LLZ·June 24, 2013
BOSTON SCIENTIFIC
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code KNT·July 29, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 8, 2019
GALAXY G3 XSFT 4MM X 8CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·April 14, 2022
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 6, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 26, 2021
SKINTACT
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code DRX·December 11, 2019
Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022