15 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CHOLESTEROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575255108·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575255085·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254996·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254613·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254972·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254590·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254941·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254606·Articulating Surfaces, CCK
Rezum System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DISPOSABLE CONTROLLED DROP PASTEUR PIPET
FDA 510(k)
FDA Class 1
·Hematology
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code FZX·June 18, 2014
COMPRESSION ANASTOMOSIS RING (CAR 27)
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD·Product code FZP·October 19, 2010
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·December 19, 2012
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