FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
7321–7344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 2024
MamaLift Plus
K223515 · SAP
Curio Digital Therapeutics, Inc.
Neurology · 517d
Cleared Apr 20, 2024
BowTie™ SI Joint Fusion System
K232149 · OUR
Sail Fusion, LLC
Orthopedic · 276d
Cleared Apr 19, 2024
SKOUT® system
K240781 · QNP
Iterative Scopes, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 19, 2024
Miro3D Fibers Wound Matrix
K240753 · KGN
Reprise Biomedical, Inc.
General & Plastic Surgery · 30d
Cleared Apr 19, 2024
Bio-Medicus Life Support Catheter and Introducer
K240534 · QHW
Medtronic, Inc.
Cardiovascular · 53d
Cleared Apr 19, 2024
Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
K240508 · LFD
Laclede, Inc.
Dental · 58d
Cleared Apr 19, 2024
FAQ™ 201, FAQ™ 202
K240378 · OHS
Foreo, Inc.
General & Plastic Surgery · 72d
Cleared Apr 19, 2024
LIFEPAK® 35 AC Power Adapter (41335-000001)
K240162 · MPD
Stryker Physio-Control
Cardiovascular · 88d
Cleared Apr 19, 2024
UniSpace® Stand-Alone C Cage
K234119 · OVE
Innosys Co., Ltd.
Orthopedic · 113d
Cleared Apr 19, 2024
SafeOp 3: Neural Informatix Systeem
K234092 · GWF
Alphatec Spine, Inc.
Neurology · 115d
Cleared Apr 19, 2024
ICE Aspiration System
K234073 · QEW
Expanse Medical, Inc.
Cardiovascular · 119d
Cleared Apr 19, 2024
ulricheasyINJECT Max 2M (XD 10140)
K233737 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 149d
Cleared Apr 19, 2024
Flowflex® Plus COVID-19 Home Test
K233373 · QYT
ACON Laboratories, Inc.
Microbiology · 200d
Cleared Apr 19, 2024
AccuCath Ace™ Intravascular Catheter
K233106 · FOZ
Bard Access Systems, Inc. (C.R. Bard,...
General Hospital · 205d
Cleared Apr 19, 2024
Electrical Neuromuscular Stimulator, Cure Trio
K233046 · GZJ
Oriental Inspiration Limited
Neurology · 207d
Cleared Apr 19, 2024
Patient Monitor (iX10, iX12, iX15)
K232962 · MHX
Edan Instruments, Inc.
Cardiovascular · 211d
Cleared Apr 19, 2024
NewPort Spinal System
K232566 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 239d
Cleared Apr 19, 2024
Healgen Rapid COVID-19 Antigen Test
K232377 · QVF
Healgen Scientific, LLC
Microbiology · 255d
Cleared Apr 19, 2024
Patriot-SI Posterior Implant System
K232259 · OUR
Spinal Simplicity, LLC
Orthopedic · 263d
Cleared Apr 19, 2024
Hemoblock_S (Prescription)
K232216 · QSY
Incore Co., Ltd.
General & Plastic Surgery · 268d
Cleared Apr 19, 2024
ReyaGel (RG03 - MTP gel 3mL)
K232204 · KGN
Fettech
General & Plastic Surgery · 269d
Cleared Apr 19, 2024
APTUS Foot System 2.8-3.5
K232105 · HRS
Medartis AG
Orthopedic · 280d
Cleared Apr 19, 2024
KeYi Total Knee System
K230120 · JWH
Beijing Keyi Medical Device...
Orthopedic · 458d
Cleared Apr 18, 2024
Disposable Medical Face Mask (M643BE)
K240258 · FXX
Makrite Industries, Inc.
General Hospital · 78d