14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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