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
5833–5856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2024
SPECTRALIS with Flex Module
K241163 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 168d
Cleared Oct 11, 2024
Progressive Orthodontics App
K241153 · PNN
Progressive Aligners, Inc.
Dental · 168d
Cleared Oct 11, 2024
Reprocessed DECANAV™ Electrophysiology Catheter
K240826 · NLH
Sterilmed, Inc.
Cardiovascular · 199d
Cleared Oct 11, 2024
PPH Saliva Collection Kit
K240797 · QBD
Permantis Public Health
Microbiology · 203d
Cleared Oct 11, 2024
Spark™ Clear Aligner System
K240501 · NXC
Ormco Corporation
Dental · 233d
Cleared Oct 11, 2024
ARTAIRA Arterial Compression Device (AACD01)
K240499 · JOW
Airos Medical, Inc.
Cardiovascular · 234d
Cleared Oct 11, 2024
PBM Hair Therapy Cap
K240472 · OAP
Dongguan Tutamen Metalwork Co., Ltd.
General & Plastic Surgery · 234d
Cleared Oct 11, 2024
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy...
K240242 · LCX
Anhui Deepblue Medical Technology...
Chemistry · 255d
Cleared Oct 11, 2024
JDZygoma dental implants
K240143 · DZE
Jdentalcare Srl
Dental · 267d
Cleared Oct 11, 2024
Belun Ring BLR-200 (BLR-200)
K234110 · DQA
Belun Technology Company Limited
Anesthesiology · 289d
Cleared Oct 11, 2024
Monotime and Optime R
K233265 · GAM
Peters Surgical
General & Plastic Surgery · 378d
Cleared Oct 11, 2024
QUEX ED
K232779 · OMC
Qx World, Ltd.
Neurology · 396d
Cleared Oct 11, 2024
UriSponge™
K232565 · JSM
Copan Italia Spa
Microbiology · 414d
Cleared Oct 10, 2024
uDR 380i Pro
K242515 · IZL
Shanghai United Imaging Healthcare...
Radiology · 48d
Cleared Oct 10, 2024
Dental porcelain powder
K242400 · EIH
Yilink (Tianjin) Biotechnology Co., Ltd.
Dental · 58d
Cleared Oct 10, 2024
EyeGility™ Inserter for Preloaded enVista IOLs
K242389 · MSS
Bausch & Lomb, Incorporated
Ophthalmic · 59d
Cleared Oct 10, 2024
Lasya-Trinity
K241951 · GEX
BLUECORE COMPANY Co., Ltd.
General & Plastic Surgery · 99d
Cleared Oct 10, 2024
ProSeal™ In Line Pump Set (423850)
K241735 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 115d
Cleared Oct 10, 2024
Blueprint Patient-Specific Instrumentation
K241491 · PHX
Stryker Corporation (Tornier, S.A.S.)
Orthopedic · 139d
Cleared Oct 10, 2024
EchoMeasure
K241430 · QIH
Icardio.Ai
Radiology · 142d
Cleared Oct 10, 2024
Youlaser PRIME
K241092 · GEX
Quanta System Spa
General & Plastic Surgery · 171d
Cleared Oct 10, 2024
eMVFit (MVF-10M)
K240992 · IPF
Weero Co., Ltd.
Physical Medicine · 182d
Cleared Oct 10, 2024
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
K240848 · FAJ
Ambu A/S
Gastroenterology & Urology · 197d
Cleared Oct 10, 2024
AutoChamber
K240786 · QIH
HeartLung Corporation
Radiology · 202d