11 results · 19ms · Sources: EU EUDAMED, US FDA

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OLYMPUS XCHF TYPE B180Y1

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

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014606385·MIDMARK CHIC CST 3" STANDARD

NA

FDA UDI
STRYKER CORPORATION·07613327058505·Insert, Babcock Grasper

BIOSCANNER TRIGLYCERIDES TEST STRIPS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

PALAMED BONE CEMENT

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

LIGACLIP** ENDOSCOPIC CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 26, 2013

ACCU-CHEK AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2008

TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·April 22, 2011

Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

FDA Enforcement
Class III ·Terminated·Spinal Elements, Inc·May 15, 2013

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012