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
2089–2112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2025
Swoop® Portable MR Imaging® System
K253489 · LNH
Hyperfine, Inc.
Radiology · 49d
Cleared Dec 12, 2025
TopCEM Vigor SA Self-Adhesive Resin Cement
K252785 · EMA
Rizhao Huge Biomaterials Company, Ltd.
Dental · 101d
Cleared Dec 12, 2025
Halo Sterile Single-use Radial Fiber...
K252745 · GEX
Micro-Energy Medical Technology Co.,...
General & Plastic Surgery · 105d
Cleared Dec 12, 2025
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
K252681 · KNW
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 109d
Cleared Dec 12, 2025
Revi System
K252391 · QXM
Bluewind Medical , Ltd.
Gastroenterology & Urology · 134d
Cleared Dec 12, 2025
Therapy US
K252273 · NHN
Dmc Importa??o E Exporta??o DE...
Physical Medicine · 143d
Cleared Dec 12, 2025
Fundus On Phone Non Mydriatic (FOP NM-10)
K252120 · HKI
Remidio Innovative Solutions Private...
Ophthalmic · 158d
Cleared Dec 12, 2025
Pterygoid Indication for GM Helix Implants
K252090 · DZE
JJGC Ind?stria e Com?rcio de...
Dental · 163d
Cleared Dec 12, 2025
VizMark Preloaded Tissue Marker Device (VM-0001)
K251989 · NEU
Breast-Med, Inc.
General & Plastic Surgery · 168d
Cleared Dec 12, 2025
Self-Seal Sterilization Pouch and Roll
K251177 · FRG
Guangdong Maidi Medical Co., Ltd.
General Hospital · 240d
Cleared Dec 12, 2025
iHealth Flu A&B/COVID-19 Rapid Test
K251092 · SCA
Ihealth Labs, Inc.
Microbiology · 246d
Cleared Dec 12, 2025
EXEL Disposable Syringe
K251089 · FMF
Exelint International, Co.
General Hospital · 246d
Cleared Dec 12, 2025
iHealth Flu A&B/COVID-19/RSV Rapid Test
K251085 · SCA
Ihealth Labs, Inc.
Microbiology · 247d
Cleared Dec 12, 2025
Bio Arterial Deluxe (IC-BAP-DX)
K250974 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 256d
Cleared Dec 12, 2025
FUJIFILM Ultrasonic Endoscope EB-710US
K250863 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 266d
Cleared Dec 12, 2025
VaporShield
K250847 · MEG
Vault Paragon Group, Inc.
General Hospital · 267d
Cleared Dec 12, 2025
Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon...
K250821 · DTZ
Eurosets S.R.L
Cardiovascular · 269d
Cleared Dec 12, 2025
Cerynë Intimate Care
K250488 · NUC
Ansella Therapeutics
Obstetrics & Gynecology · 296d
Cleared Dec 12, 2025
Jason membrane
K242817 · NPL
Botiss Biomaterials GmbH
Dental · 450d
Cleared Dec 11, 2025
Cervical Spine Truss System - Stand Alone (CSTS-SA)
K253200 · OVE
4Web Medical, Inc.
Orthopedic · 76d
Cleared Dec 11, 2025
DeepRhythmAI
K253141 · DQK
Medicalgorithmics S.A.
Cardiovascular · 77d
Cleared Dec 11, 2025
HyperFlex® Bunion Correction System
K252997 · HRS
Hyperflex Medical
Orthopedic · 84d
Cleared Dec 11, 2025
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
K252941 · FXX
O&M Halyard, Inc.
General Hospital · 87d
Cleared Dec 11, 2025
APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw)
K252897 · HRS
A Plus Biotechnology Co., Ltd.
Orthopedic · 91d