15 results
·
27ms
·
Sources: EU EUDAMED, US FDA
'HILT-WAY' RESUSCITATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575246281·Articulating Surfaces, CR
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575255306·Articulating Surfaces, CR
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575255320·Articulating Surfaces, CR
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575255269·Articulating Surfaces, CR
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575255238·Articulating Surfaces, CR
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575255252·Articulating Surfaces, CR
Orthocaps Twinaligner
FDA 510(k)
FDA Class 2
·Dental
DDS STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACS
FDA Adverse Event
Malfunction
·AMERICAN CONTRACT SYSTEMS·Product code LRO·October 15, 2024
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 22, 2010
SROM STM ST,36+6L NK,11X16X150
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·December 19, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2014
DREAMSTATION AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·October 25, 2022
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025