20 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254231·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254187·Articulating Surfaces, CCK
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880231180·dentaform® Snap Band, Tooth 46, Size 31/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880231000·dentaform® Snap Band, Tooth 46, Size 31
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254200·Articulating Surfaces, CCK
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880231220·dentaform® Snap Band, Tooth 46, Size 31/Roth 22
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575245475·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254194·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254224·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254217·Articulating Surfaces, CCK
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575254170·Articulating Surfaces, CCK
ABCO/GRANT ALTERNATING PRESSURE PAD & UT
FDA 510(k)
FDA Class 2
·General Hospital
BANDAGE, ELASTIC
FDA 510(k)
FDA Class 1
·General Hospital
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 18, 2014
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 22, 2010
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·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
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026