16 results
·
33ms
·
Sources: EU EUDAMED, US FDA
CHIROFLEX II LENS MICROSERT(TM)
FDA 510(k)
FDA Class 3
·Ophthalmic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450096598·
Votion®
FDA UDI
Ortho Organizers, Inc.·00190707114572·Votion .018 R LL3 HK -11T 7A 2MO (10PK) VOTION
Pinnacle®
FDA UDI
Ortho Organizers, Inc.·00190707112646·Pinnacle .018 R LL3 HK -11T 7A 2MO (10PK)
Pinnacle
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730010704·Pinnacle .018 R LL3 HK -11T 7A 2MO (10PK)
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730008879·Votion .018 R LL3 HK -11T 7A 2MO (10PK)
RUMI II KOH-EFFICIENT
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HEW·October 20, 2022
ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
RHEUMAGEN ASO T-CONTROL
FDA 510(k)
FDA Class 1
·Microbiology
KOH-EFFICIENT,RUMI
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HEW·November 4, 2022
KOH-EFFICIENT,RUMI
FDA Adverse Event
Injury
·COOPERSURGICAL, INC.·Product code HEW·November 3, 2022
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD.·Product code HQL·November 15, 2010
TOTAL ASR FEM IMP SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·July 3, 2014
S3 EX - 3005
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 6, 2012
Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020