21 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR)
FDA 510(k)
FDA Class 1
·General Hospital
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70604021·Mini-Mono-Brackets Edgew. 'N' .018" 100 Brackets
LEONE SPA
FDA UDI
LEONE SPA·08033707065661·INTRAORAL ELASTICS 2,5 oz 5/16" blue
Rumor
FDA UDI
Ortho Organizers, Inc.·00190707003920·Rumor .022 UR2 8T 9A 0O
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0600020·Tray Insert, Level 2
Tablet Battery
FDA UDI
Orthosoft Inc·00887868523908·
SMOOTH-FLO CIRCUIT
FDA 510(k)
FDA Class 2
·Anesthesiology
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
FDA 510(k)
FDA Unclassified
·Unknown
COBAS® WNV NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 29, 2025
CORMET RESURFACING
FDA Adverse Event
CORIN LTD·Product code NXT·April 11, 2013
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code MMI·September 4, 2014
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·April 15, 2011
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·August 19, 2025
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
FDA Enforcement
Class II
·Ongoing·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·November 26, 2025
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 20, 2017
CORMATRIX ECM FOR PERICARDIAL CLOSURE
FDA Adverse Event
Injury
·AZIYO BIOLOGICS, INC.·Product code DXZ·November 16, 2017
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
FDA Recall
Open, Classified
·ASP Global, LLC. dba Anatomy Supply Partners, LLC.·Product code GIO·September 26, 2025
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022