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
18025–18048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2021
Medical Face Mask
K202493 · FXX
Gemtier Medical (Shanghai), Inc.
General Hospital · 157d
Cleared Feb 04, 2021
Prase PEEK Anterior Cervical Interbody Spacer
K202872 · ODP
Gbs Commonwealth Co., Ltd.
Orthopedic · 129d
Cleared Feb 04, 2021
RESPONSE Navigation Instruments
K203573 · OLO
OrthoPediatrics Corp.
Orthopedic · 59d
Cleared Feb 04, 2021
QUIBIM Precision Prostate (qp-Prostate)
K203582 · LLZ
Quibim S.L.
Radiology · 59d
Cleared Feb 04, 2021
BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
K210174 · NGX
Bemer Int AG
Physical Medicine · 13d
Cleared Feb 03, 2021
Jiajian Self-Adhesive Electrode
K192568 · GXY
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 504d
Cleared Feb 03, 2021
UNiTi ACDF Implant System
K200301 · PHQ
Pressio, Inc.
Orthopedic · 363d
Cleared Feb 03, 2021
AXUS ES-5 Electro-Acupuncture Device
K200636 · BWK
Lhasa Oms, Inc.
Neurology · 330d
Cleared Feb 03, 2021
Balex bone Expander System
K202027 · HRX
Taeyeon Medical Co., Ltd.
Orthopedic · 196d
Cleared Feb 03, 2021
Smart SPACE Shoulder System
K202151 · QHE
Techmah Medical, LLC
Orthopedic · 184d
Cleared Feb 03, 2021
Medical Face Masks
K202627 · FXX
Guilin Hbm Sanitary Protections, Inc.
General Hospital · 145d
Cleared Feb 03, 2021
Arthrex Pilon Fusion System
K203294 · HRS
Arthrex, Inc.
Orthopedic · 86d
Cleared Feb 03, 2021
EcoFit® Hip System
K203420 · LZO
Implantcast GmbH
Orthopedic · 76d
Cleared Feb 03, 2021
Omnichroma Flow Bulk
K203598 · EBF
Tokuyama Dental Corporation
Dental · 56d
Cleared Feb 02, 2021
Easydrip Pen Needle, Easydrip Plus Pen Needle
K193422 · FMI
Sandstone Medical (Suzhou), Inc.
General Hospital · 421d
Cleared Feb 02, 2021
CTxx85 CT Scanner
K201231 · JAK
Analogic Corporation
Radiology · 271d
Cleared Feb 02, 2021
3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On
K202096 · FXX
Ecoguard, Inc.
General Hospital · 188d
Cleared Feb 02, 2021
Fundus Camera
K202097 · HKI
Huvitz Co., Ltd.
Ophthalmic · 188d
Cleared Feb 02, 2021
Disposable Medical Surgical Masks
K202323 · FXX
Tianjin Teda Jinshan Easy Packing...
General Hospital · 169d
Cleared Feb 02, 2021
Medical Face Mask
K202331 · FXX
Gemtier Medical (Shanghai), Inc.
General Hospital · 169d
Cleared Feb 02, 2021
Disposable Medical Surgical Mask
K202511 · FXX
Improve Medical (Hunan) Co., Ltd.
General Hospital · 155d
Cleared Feb 02, 2021
INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers,...
K203278 · MAX
Globus Medical, Inc.
Orthopedic · 88d
Cleared Feb 02, 2021
CellFX System
K203299 · GEI
Pulse Biosciences, Inc.
General & Plastic Surgery · 85d
Cleared Feb 02, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
K203553 · LNH
Canon Medical Systems Corporation
Radiology · 60d