18 results
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21ms
·
Sources: EU EUDAMED, US FDA
ARTHROBOT(TM) LOWER LIMB POSITIONER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880227220·dentaform® Snap Band, Tooth 46, Size 27/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880227000·dentaform® Snap Band, Tooth 46, Size 27
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254064·Articulating Surfaces, PS+
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254095·Articulating Surfaces, PS+
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254057·Articulating Surfaces, PS+
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254088·Articulating Surfaces, PS+
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254101·Articulating Surfaces, PS+
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254071·Articulating Surfaces, PS+
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880227180·dentaform® Snap Band, Tooth 46, Size 27/Roth 18
LINKSYMPHOKNEE
FDA Adverse Event
Injury
·WALDEMAR LINK GMBH & CO. KG·Product code KRO·May 18, 2022
Polaris Spinal Growth System
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
MALLINCKRODT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code BTS·April 8, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·October 22, 2010
PERISTEEN ANAL IRRIGATION SYSTEM
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code KNT·December 19, 2012
Angiotech Galactography Kit. Galactography Kit 30ga with Straight Cannula and Galactography Kit 30ga with Curved Cannula. STERILE. Product Number: DGK002SX, DGK002X. 510k K980227. Qty Dist. - 2,630. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Injection Media Contrast Kit Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code FMI·September 1, 2009
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