13 results · 29ms · Sources: EU EUDAMED, US FDA

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SURGISLEEVE WOUND PROTECTOR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Embla

FDA UDI
S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD·07290013817143·

OsteoMed

FDA UDI
OSTEOMED LLC·00845694003575·Straight Reconstruction Plate

Merit® Kit

FDA UDI
Merit Medical Systems, Inc.·00884450322420·

SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR

FDA 510(k)
FDA Class 2 ·Orthopedic

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·August 26, 2019

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

HUT EXT DR FINAL ASSY-STANDARD

FDA Adverse Event
Malfunction ·LIEBEL - FLARSHEIM CO.·Product code IXR·May 29, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·June 25, 2011

CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

FDA Adverse Event
Death ·EDWARDS LIFESCIENCES·Product code LWR·August 27, 2008

EQUINOXE SHOULDER COMPONENTS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWS·January 9, 2024

Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013