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
7033–7056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 2024
NeoSpan® Compression Implant System
K233089 · HRS
In2bones USA, LLC
Orthopedic · 241d
Cleared May 24, 2024
INSPIRA ART100
K232788 · DWA
Inspira Technologies Oxy B.H.N. , Ltd.
Cardiovascular · 256d
Cleared May 24, 2024
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6)
K232646 · KHJ
Cook Biotech Incorporated
Ear, Nose, Throat · 268d
Cleared May 24, 2024
Apollo TMS Therapy System
K232639 · OBP
Mag & More GmbH
Neurology · 268d
Cleared May 24, 2024
Racz Neurostat RF Generator
K232632 · GXD
Epimed International
Neurology · 268d
Cleared May 24, 2024
Renasys Edge
K231939 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 329d
Cleared May 24, 2024
8plant Implant System
K231426 · DZE
Hoowon Edi Co., Ltd.
Dental · 373d
Cleared May 23, 2024
uCerv Flux™-C 3D Porous Titanium Cervical Interbody
K241396 · ODP
Ulrich Medical USA, Inc.
Orthopedic · 7d
Cleared May 23, 2024
3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)
K241134 · OMP
Kci USA, Inc.
General & Plastic Surgery · 29d
Cleared May 23, 2024
Drill Guide
K240701 · OLO
Brainlab AG
Orthopedic · 70d
Cleared May 23, 2024
Syngo Carbon Enterprise Access (VA40A)
K240294 · LLZ
Siemens Healthcare GmbH
Radiology · 112d
Cleared May 23, 2024
dima Print Teeth & Temp
K233868 · EBG
Kulzer, LLC
Dental · 169d
Cleared May 23, 2024
NOxBOXi Nitric Oxide Delivery System
K233251 · MRN
Linde Gas & Equipment, Inc.
Anesthesiology · 238d
Cleared May 23, 2024
CWM-930S, FIXER DV9
K233120 · GEI
Chungwoo Co., Ltd.
General & Plastic Surgery · 239d
Cleared May 23, 2024
VinDr-Mammo
K233108 · QFM
Vinbigdata Joint Stock Company
Radiology · 239d
Cleared May 23, 2024
AirKEE T900
K232642 · FRA
Healkee Medical Pte, Ltd.
General Hospital · 267d
Cleared May 23, 2024
CamAPS FX
K232603 · QJI
Camdiab , Ltd.
Chemistry · 269d
Cleared May 23, 2024
3DMatrix Surgical Mesh
K232602 · OXF
Printbio, Inc.
General & Plastic Surgery · 269d
Cleared May 22, 2024
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K241143 · QHE
Materialise NV
Orthopedic · 27d
Cleared May 22, 2024
OviTex PRS
K241126 · FTM
TELA Bio, Inc.
General & Plastic Surgery · 29d
Cleared May 22, 2024
Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A,...
K241106 · OHT
Shenzhen Mlay Intelligent Technology...
General & Plastic Surgery · 30d
Cleared May 22, 2024
Rapid Urine Fentanyl (FYL) Test Strip
K241100 · NGL
Co-Innovation Biotech Co., Ltd.
Toxicology · 30d
Cleared May 22, 2024
Biomet Kirschner Wires (K-Wires)
K241014 · HTY
Biomet, Inc.
Orthopedic · 40d
Cleared May 22, 2024
Bosley Booster 128 Laser Cap
K240456 · OAP
Plm Worldwide, LLC D/B/A Phoenix...
General & Plastic Surgery · 97d