FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
19081–19104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2020
EchoPAC Software Only, EchoPAC Plug-In
K200852 · LLZ
GE Medical Systems Ultrasound and...
Radiology · 171d
Cleared Sep 18, 2020
Optixon 1-Day
K201013 · LPL
Optixon, Inc.
Ophthalmic · 154d
Cleared Sep 18, 2020
Seaspine WaveForm C Interbody System
K201073 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 149d
Cleared Sep 18, 2020
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and...
K201207 · KOC
Fresenius Medical Care Renal...
Gastroenterology & Urology · 136d
Cleared Sep 18, 2020
Electrosurgical Generator and Accessories
K201224 · GEI
Medrange
General & Plastic Surgery · 135d
Cleared Sep 18, 2020
Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with...
K201390 · LZC
Medline Industires, Inc.
General Hospital · 114d
Cleared Sep 18, 2020
Life Spine SIMPACT Sacroiliac Joint Fixation System
K201538 · OUR
Life Spine, Inc.
Orthopedic · 101d
Cleared Sep 18, 2020
B&J DVT Foot Garments, Models 820 Series
K201547 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 101d
Cleared Sep 18, 2020
Paragon Adult Maxi PMP Oxygenator with Tubing Pack
K201642 · DTZ
Chalice Medical , Ltd.
Cardiovascular · 93d
Cleared Sep 18, 2020
SMS Cementless Stem
K201673 · LZO
Medacta International S.A.
Orthopedic · 91d
Cleared Sep 18, 2020
Tempus Pro Patient Monitor
K201746 · MHX
Remote Diagnostic Technologies Limited
Cardiovascular · 84d
Cleared Sep 18, 2020
Caption Guidance
K201992 · QJU
Caption Health
Radiology · 63d
Cleared Sep 18, 2020
GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made...
K202022 · JWH
Medacta International S.A.
Orthopedic · 58d
Cleared Sep 18, 2020
Ran-Flex-B Bone Marrow Aspiration Needle
K202287 · KNW
Ranfac Corporation
General & Plastic Surgery · 37d
Cleared Sep 18, 2020
OrthoButton FL
K202399 · MBI
Riverpoint Medical
Orthopedic · 28d
Cleared Sep 18, 2020
Disposable Surgical Mask
K202463 · FXX
Unisources Group, LLC
General Hospital · 22d
Cleared Sep 17, 2020
Portable Electro-Stimulation Therapy Device
K182020 · NGX
Guangzhou Longest Science &...
Physical Medicine · 783d
Cleared Sep 17, 2020
EUROIMMUN Anti-BP230-CF ELISA (IgG)
K193115 · OEG
Euroimmun Us, Inc.
Immunology · 310d
Cleared Sep 17, 2020
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
K201494 · DJG
Advin Biotech, Inc.
Toxicology · 104d
Cleared Sep 17, 2020
GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE...
K201686 · OTN
Ethicon, Inc.
Gastroenterology & Urology · 87d
Cleared Sep 17, 2020
Single-Use Surgical Mask With Ear Loop
K201691 · FXX
Qiqihar Hengxin Medical Supplies, Ltd.
General Hospital · 87d
Cleared Sep 17, 2020
eNAT molecular collection and preservation medium
K201849 · QBD
Copan Italia Spa
Microbiology · 73d
Cleared Sep 17, 2020
LZI Oxycodone III Enzyme Immunoassay
K202007 · DJG
Lin-Zhi International, Inc.
Toxicology · 58d
Cleared Sep 17, 2020
STRUXXURE®-L and STRUXXURE®-A Plate System
K202192 · KWQ
Nexxt Spine, LLC
Orthopedic · 43d