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