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

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SAGITTAL SAW

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

THD N-Ano anoscopes

FDA UDI
THD SPA·08051887044719·THD N-ano Digital is a disposable medical devic...

Mini-Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78003131·Mini Sprint Bracket McLaugh/Benn/Trev. .018" ma...

ACUMED

FDA UDI
Acumed LLC·10806378041112·Univ Tray Base Olec Threaded Compr Rod

NAR Kit

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209100965·KIT, NAR-4 AID w' CHITOGAUZE - MTC; This kit co...

Denovo Dental Three Jaw Plier - To .036 Wire

FDA UDI
Denovo Dental, Inc.·00810059291645·Denovo Dental Three Jaw Plier - To .036 Wire

Mini-Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78003131001·Mini Sprint Bracket McLaugh/Benn/Trev. .018" ma...

Mini-Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78003130051·Mini Sprint Bracket McLaugh/Benn/Trev. .018" ma...

Mini-Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78003130101·Mini Sprint Bracket McLaugh/Benn/Trev. .018" ma...

iNSitu™ Hip System

FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127028809·Blade Femoral Broach Size 13

TEARAWAY INTRODUCER SHEATH

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO EXPEDIUM SPINE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

GIA 60 - 3.8 SINGLE USE RELOADABLE STAPLER

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GDW·May 2, 2014

REMANUFACTURED BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·October 9, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 28, 2007

Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Claw" Tips are bone cutting tips which are a part of Strykers Neuro Spine Ear, Nose and Throat (ENT) Sonopet Portfolio. They are removable attachments intended to be used with the Sonopet Ultrasonic Handpiece.

FDA Enforcement
Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·April 20, 2016

Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Claw" Tips are bone cutting tips which are a part of Strykers Neuro Spine Ear, Nose and Throat (ENT) Sonopet Portfolio. They are removable attachments intended to be used with the Sonopet Ultrasonic Handpiece.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code LFL·March 22, 2016

Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

FDA Enforcement
Class I ·Terminated·Cook Inc.·March 2, 2016

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

FDA Enforcement
Class II ·Terminated·Beckman Coulter Inc.·November 12, 2014