23 results
·
20ms
·
Sources: EU EUDAMED, US FDA
FUJIFILM Endoscope Models EC-600HL and EC-600LS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768499·GENUMEDI PSS GREEN V
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486000431·MCK Patellofemoral Component
Mouse anti-TS Cocktail (TS106/4H4B1) Concentrate
FDA UDI
LIFE TECHNOLOGIES CORPORATION·10190302008044·
BONASTENT® Tracheal/Bronchial
FDA UDI
Sewoon Medical Co., Ltd.·08806369468985·
FUKUSHIMA SUCTION TUBE
FDA UDI
SONTEC INSTRUMENTS, INC.·B0991804050·FUKUSHIMA SUCTION TUBE
FUKUSHIMA SUCTION TUBE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896000339·FUKUSHIMA SUCTION TUBE
N/A
FDA UDI
Ortho Development Corporation·00822409128938·4-in-1 Cut Guide w/ Anterior Lip Size 5
FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYGNAL DBM
FDA 510(k)
FDA Class 2
·Orthopedic
ARROR STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code BSP·September 8, 2014
ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code BSP·September 8, 2014
ARROW STIM CPNB TUOHY NDL: 18G X 4CM (1-1/2")
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code BSP·September 8, 2014
MED-EL MAESTRO COCHLEAR IMPLANT SYS
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·October 15, 2014
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·July 27, 2011
IDC?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRD·June 20, 2013
BACT/ALERT MP - 419744
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·December 5, 2019
DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·May 27, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020