23 results · 20ms · Sources: EU EUDAMED, US FDA

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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