23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GR40CW
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768451·GENUMEDI PSS GREEN I
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551057728·BUCK Ear Curette. Sharp, Size 1
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100318·ALPHONSO INFANT SPECULUM
Anatotemp
FDA UDI
BUCKEYE MEDICAL TECHNOLOGIES, LLC·D7861534010·Anatotemp Anatomic Dental Implant Healing Abutm...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100356·COOK EYE SPECULUM #1 SOLID
STINGRAY LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ORTHO-1(NOT FINALIZED)
FDA 510(k)
FDA Class 2
·Dental
NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·September 26, 2019
STINGRAY? LP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 13, 2010
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 8, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 8, 2014
RADIAL JAW 3 HOT BIOPSY FORCEPS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KGE·August 21, 2008
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MMI·April 15, 2010
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·April 5, 2010
Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.
FDA Enforcement
Class II
·Ongoing·Canary Medical, Inc.·July 16, 2025
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 13, 2022