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

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CurvaFix Low Profile System

FDA 510(k)
FDA Class 2 ·Orthopedic

Darby Dental Supply, LLC

FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813525296·DERMASILK NITRILE GLOVE M

FPS

FDA UDI
Tyber Medical, LLC·00810040686337·Ø2.5mm Locking Screw, VA 19mm

TMS SYSTEM

FDA UDI
BIOMET MICROFIXATION, INC·00841036089474·

ceraMotion®

FDA UDI
DENTAURUM GmbH & Co.KG·J011252019200·ceraMotion® Me Opaque Modifier orange, 20 g / d...

NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE

FDA 510(k)
FDA Class 2 ·Physical Medicine

HairMD

FDA 510(k)
FDA Class 2 ·Physical Medicine

NA

FDA UDI
Exactech, Inc.·10885862523952·TRIAL, TIBIAL INSERT, SPACER, SIZE 0, 19mm

MEDFUSION 3500 SYRINGE INFUSION PUMP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·March 28, 2023

CONFIDA BRECKER CURVE GUIDEWIRE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DQX·July 2, 2025

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·March 28, 2019

V-PRO STERILIZER

FDA Adverse Event
STERIS MEXICO, S. DE R.L. DE C.V.·Product code MLR·September 16, 2011

SYNCHROMED EL

FDA Adverse Event
Injury ·RICE CREEK MANFUACTURING·Product code LKK·December 4, 2008

TRIAL SPACER HANDLE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HTD·July 29, 2013

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

Set-Up Pack, part number PSS1305(C

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pack, part number AMS6012 Custom Pack, part number AMS6383 Custom Pack, part number PSS2135(B Custom Pack, part number PSS2798(B Custom Pack, part number PSS2798(C Custom Pack, part number PSS3463

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

Canon Aquilion Prime, Model TSX-303A

FDA Recall
Open, Classified ·Canon Medical System, USA, INC.·Product code JAK·March 25, 2019

Canon Aquilion One, Model TSX-301A

FDA Recall
Open, Classified ·Canon Medical System, USA, INC.·Product code JAK·March 25, 2019

Canon Aquilion Premium, Model TSX-301B

FDA Recall
Open, Classified ·Canon Medical System, USA, INC.·Product code JAK·March 25, 2019