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
8569–8592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2023
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT...
K233084 · ODP
Gbs Commonwealth Co., Ltd.
Orthopedic · 56d
Cleared Nov 21, 2023
DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size...
K233053 · MUH
Dental Imaging Technologies Corporation
Radiology · 57d
Cleared Nov 21, 2023
TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant...
K233049 · PSW
Cs Medical, LLC
General Hospital · 57d
Cleared Nov 21, 2023
Beagank 4T Plus
K233010 · NFO
Belega, Inc.
Neurology · 60d
Cleared Nov 21, 2023
Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System
K232988 · IYN
Canon Medical Systems Corporation
Radiology · 60d
Cleared Nov 21, 2023
Biophotas Celluma CONTOUR
K232977 · OLI
Biophotas, Inc.
General & Plastic Surgery · 61d
Cleared Nov 21, 2023
Quantisal™ Oral Fluid Collection Device
K232898 · PJD
Immunalysis Corporation
Chemistry · 64d
Cleared Nov 21, 2023
ProMIS Extension Rod System
K232719 · NKB
Premia Spine, Ltd.
Orthopedic · 77d
Cleared Nov 21, 2023
Medical Nitrile Examination Gloves
K232576 · LZA
Jiangsu Complete Sincerity Medical...
General Hospital · 88d
Cleared Nov 21, 2023
INFINITI™ Ambi Angiographic Catheter
K232573 · DQO
Cordis US Corp
Cardiovascular · 88d
Cleared Nov 21, 2023
NemoCast
K232549 · PNN
Software Nemotec S.L.
Dental · 90d
Cleared Nov 21, 2023
Meta G UCLA Abutment
K232546 · NHA
Cowellmedi Co., Ltd.
Dental · 90d
Cleared Nov 21, 2023
Brainomix 360 Triage Stroke
K232496 · QAS
Brainomix Limited
Radiology · 96d
Cleared Nov 21, 2023
High Pressure Tubing
K232388 · DXT
Ningbo Dizegens Medical Science Co.,Ltd
General Hospital · 104d
Cleared Nov 21, 2023
Nu Skin RenuSpa iO
K232001 · NFO
Nse Products, Inc.
Neurology · 139d
Cleared Nov 21, 2023
PNK Total Knee System
K231975 · JWH
Tjc Life Co., Ltd.
Orthopedic · 141d
Cleared Nov 21, 2023
Mini-OSTEO Pedicle Fixation System
K231443 · NKB
Osteomed Ind?stria E Com?rcio DE...
Orthopedic · 187d
Cleared Nov 21, 2023
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
K230834 · DPS
Trismed Co., Ltd.
Cardiovascular · 239d
Cleared Nov 21, 2023
Endoscopy Irrigation Tubing
K230773 · OCX
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 245d
Cleared Nov 21, 2023
Ultrasonic Scaler Tips
K230641 · ELC
Guilin Refine Medical Instrument Co.,...
Dental · 258d
Cleared Nov 21, 2023
SaviSafe Safety Device
K230287 · MEG
Suzhou Savicred Biotechnology Co., Ltd.
General Hospital · 292d
Cleared Nov 21, 2023
CranioXpand
K230211 · PBJ
KLS-Martin L.P.
Neurology · 299d
Cleared Nov 21, 2023
Digital ClarusScope System, Digital NeuroPEN System
K223615 · GWG
Clarus Medical, LLC
Neurology · 351d
Cleared Nov 21, 2023
Oxy2Pro
K222511 · CCK
Southmedic, Inc.
Anesthesiology · 459d