27 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI
FDA 510(k)
FDA Class 1
·General Hospital
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00210111·
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040044544·Splinter Forcep 4.5"
artVeneer life
FDA UDI
Merz Dental GmbH·D7092002111·artVeneer life lower posteriors, XL, C3
BetaForce
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730022004·Beta3 Upper 19x25 10 archwires per pack
BetaForce™
FDA UDI
Ortho Organizers, Inc.·00190707124410·BETAFORCE Beta³ Upper 19x25 (10pk)
ANCA Test System
FDA UDI
IMMUNO CONCEPTS INC·M749100211121·pANCA Positive Control - 2 x 1 ml.
MODIFICATION TO INTRALASE 600C LASER KERATOME
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PANORET, MODEL 1000A
FDA 510(k)
FDA Class 2
·Ophthalmic
CRONIN SILASTIC BREAST IMPLANT
FDA Adverse Event
Injury
·DOW CORNING CORP.·Product code FTR·May 19, 1994
HEYER-SCHULTE SALINE BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR CORP.·Product code FWM·May 19, 1994
HEYER-SCHULTE SALINE BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR CORP.·Product code FWM·May 19, 1994
INTACS PRESCRIPTION INSERTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 11, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·February 4, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 20, 2008
INTACS PRESCRIPTION INSERTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006
INJECTOR N35-O
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·December 17, 2020
INTACS CORNEAL IMPLANTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006
INTACS PRESCRIPTION INSERTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006