16 results
·
28ms
·
Sources: EU EUDAMED, US FDA
MICROGENICS CYCLOSPORINE CONTROL KIT
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032842·Baltic Denture System BDLoad Sm6 PLSEbm6DFs A4 ...
INSTANT-VIEW Buprenorphine/ Norbuprenorphine Urine Cassette Test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000153·INSTANT-VIEW Buprenorphine/ Norbuprenorphine Ur...
V*CARE MANUAL RESUSCITATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
STEPHENS DISPOSABLE HOOKS
FDA 510(k)
FDA Class 1
·Ophthalmic
NONE - SEE PHYSICIAN COMMENTS IN H10.
FDA Adverse Event
Injury
·Product code JWH·October 16, 2013
PEN NDL 31G 5MM XTW 5B 100CT AP
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FMI·July 8, 2020
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 3, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 29, 2011
UNKNOWN ALUMINA HEAD
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·April 22, 2008
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·October 15, 2025
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·December 19, 2025
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·August 16, 2022
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024