19 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
FDA 510(k)
FDA Class 2
·Cardiovascular
Catheter and Glove Suction Kit
FDA UDI
C. R. Bard, Inc.·00801741050671·Catheter and Glove Suction Kit with Solution Co...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694003599·Medium 4 Hole BSSO Plate
OsteoMed
FDA UDI
OSTEOMED LLC·00845694031059·BSSO Plate, Mini, 4 Hole, Medium, Sterile
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981179656·Z-Rod, Dia. 6.0mm, Co-Cr, 80mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694064354·2.0 System 4 Hole Medium BSSO Plate Sterile Qty 5
REPROCESSED TROCARS, MODEL B5LT AND CB5LT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AESCULAP ABSORBABLE CRANIOFIX
FDA 510(k)
FDA Class 2
·Neurology
HAHN TAPERED IMPLANT Ø3.5 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 7, 2025
HAHN TAPERED IMPLANT Ø3.5 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 10, 2025
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC·Product code CBK·May 29, 2013
SYNCHRON LX® RHEUMATOID FACTOR REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHR·June 25, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code HQL·August 28, 2008
HAHN TAPERED IMPLANT Ø3.5 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 20, 2024
BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·November 22, 2022
CATHETER AND GLOVE SUCTION KIT WITH SOLUTION CONTAINER, TWO VINYL GLOVES, TWO EY
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code BSY·May 10, 2018
CATHETER AND GLOVE SUCTION KIT WITH SOLUTION CONTAINER, TWO VINYL GLOVES, TWO EY
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code BSY·May 10, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013