25 results · 33ms · Sources: EU EUDAMED, US FDA

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SHASER HRS2 HAIR REMOVAL SYSTEM

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

EVO 2 ST

FDA UDI
DENTAL MANUFACTURING SPA·08056865012803·

OsteoMed

FDA UDI
OSTEOMED LLC·00845694002691·Orbital Plate

Stryker

FDA UDI
Provision·B504OM51200800300·

RIVA Posterior Fixation System

FDA UDI
XENIX MEDICAL LLC·00840493418650·CONSTRAINED LORDOTIC ROD, 5.5mm x 80mm

RIVA Pedicle Screw System

FDA UDI
XENIX MEDICAL LLC·00840493418865·CONSTRAINED LORDOTIC ROD, 6.0mm x 80mm

OsteoMed

FDA UDI
OSTEOMED LLC·00845694063623·1.2 System Hole Orbital Plate Sterile Qty 2

NA

FDA UDI
STRYKER CORPORATION·07613154570188·1.6mm x 5.5mm Metal Cutting Heliocoidal Rasp

NA

FDA UDI
STRYKER CORPORATION·04546540078728·3.2mm x 18.3mm Metal Cutting Heliocoidal Rasp

BONART ART-E1 ELECTROSURGERY UNIT

FDA 510(k)
FDA Class 2 ·Dental

REPROCESSED TROCARS, MODEL B5LT AND CB5LT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 22, 2021

SYRINGE 20ML LL S/C 48

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·May 9, 2024

BIOMET TIBIAL LOCKING BAR

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·May 20, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 25, 2014

MALLINCKRODT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·June 7, 2011

SYRINGE 20ML LL S/C 48

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·May 10, 2024

EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·September 7, 2022

NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.

FDA Enforcement
Class III ·Terminated·Nidek, Inc.·January 8, 2020

MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

FDA Enforcement
Class II ·Ongoing·Auris Health, Inc·February 25, 2026