14 results · 23ms · Sources: EU EUDAMED, US FDA

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EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040009383·Zirlux 16+ P3 coloring liquid

INTER FIX™ RP Threaded Fusion Device

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978957401·16X20 INTERFIXRP FUSION DEVICE

DD tempMED

FDA UDI
Dental Direkt GmbH·EDDIK116201·DD tempMED are pre-colored dental milling blank...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07310K0115200·Needle, Bevel Stylet, Stainless Steel, Disposable

ENDOSCOPIC STAPLE REMOVAL INSTRUMENT

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

METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN

FDA 510(k)
FDA Class 2 ·Ophthalmic

3.0MM PRCSN MTCH HD, 13CM

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP·Product code HBE·July 26, 2023

CONSERVE(R) PLUS SPIKED CUP

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·March 19, 2013

COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 9, 2011

DUAL EXTENSION CARRIER

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·March 10, 2008

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018