21 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
APEX 3D Total Ankle Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114261·CHAMBER MAINTAINER 23GA (PK/10)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113301·STAB KNIFE 45 DEGREE (BX/5)
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112588·BARRON CORNEAL PUNCH 6.75MM
CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
FDA 510(k)
FDA Class 2
·Radiology
CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS
FDA 510(k)
FDA Class 1
·Ophthalmic
DURASEAL SEALANT SYSTEM 5ML (QTY 5) US
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code NQR·August 3, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 2, 2013
EVIS EXERA III COLONOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDF·September 13, 2023
SMARTSET GHV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code MBB·May 8, 2025
MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·March 8, 2024
TC3 RP TIBIAL INSERT S5,20.0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NJL·December 19, 2024
LCS CRUC M/B PAT REPLC GVF LG+
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code NJL·December 19, 2024
SMARTSET GHV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code MBB·May 8, 2025
SMARTSET GHV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code MBB·May 8, 2025
SMARTSET GHV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code MBB·May 8, 2025
MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·March 8, 2024
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021