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
10297–10320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2023
Genius AI Detection 2.0 with CC-MLO Correlation
K230096 · QDQ
Hologic, Inc.
Radiology · 130d
Cleared May 23, 2023
Ceribell Status Epilepticus Monitor
K223504 · OMB
Ceribell, Inc.
Neurology · 182d
Cleared May 22, 2023
3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
K231464 · NXC
3M Company, Unitek Orthodontic Products
Dental · 3d
Cleared May 22, 2023
TracStar LDP Large Distal Platform
K231168 · QJP
Imperative Care, Inc.
Neurology · 27d
Cleared May 22, 2023
Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)
K230708 · ODP
Gbs Commonwealth Co., Ltd.
Orthopedic · 69d
Cleared May 22, 2023
Kodiak™ Dual Port Coaxial Introducer Kit
K230631 · DYB
Argon Medical Devices
Cardiovascular · 76d
Cleared May 22, 2023
Hi-Bond Universal
K230465 · KLE
Mediclus Co., Ltd.
Dental · 90d
Cleared May 22, 2023
MixJect® Transfer Device
K230464 · LHI
West Pharma Services Il, Ltd.
General Hospital · 90d
Cleared May 22, 2023
Laser Thermal Therapy Kit
K230460 · GEX
Elesta S.P.A
General & Plastic Surgery · 90d
Cleared May 22, 2023
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
K230443 · NUH
Jiangxi Royall Smart Technology Co.,...
Neurology · 90d
Cleared May 22, 2023
HELIOS 785 Pico
K230373 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 98d
Cleared May 22, 2023
Integrity™ Bone Staple Fixation System
K223860 · MBI
Anika Therapeutics, Inc.
Orthopedic · 150d
Cleared May 22, 2023
TrueBeam, TrueBeam STx, Edge, VitalBeam
K223839 · IYE
Varian Medical Systems, Inc.
Radiology · 151d
Cleared May 22, 2023
Introducer Needle
K222705 · LJE
Youcare Technology Co.,Ltd. (Wuhan)
General & Plastic Surgery · 257d
Cleared May 22, 2023
PVC Hydrophilic Urethral Catheter
K220722 · EZD
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 434d
Cleared May 19, 2023
GI Genius System 100 and GI Genius System 200
K231143 · QNP
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 28d
Cleared May 19, 2023
aprevo® transforaminal lumbar interbody fusion device
K231140 · MAX
Carlsmed, Inc.
Orthopedic · 28d
Cleared May 19, 2023
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
K231137 · DKZ
Xenta Biomedical Science Co., Ltd.
Toxicology · 28d
Cleared May 19, 2023
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c...
K230790 · DHA
Abbott Laboratories
Chemistry · 58d
Cleared May 19, 2023
PrevisEA Device
K230769 · DQD
Entac Medical, Inc.
Gastroenterology & Urology · 60d
Cleared May 19, 2023
Klassic Knee Revision System
K230537 · JWH
Total Joint Othopedics, Inc.
Orthopedic · 81d
Cleared May 19, 2023
Triathlon® Hinge Knee System
K230416 · KRO
Stryker
Orthopedic · 92d
Cleared May 19, 2023
BIOMONITOR IV
K230375 · MXD
Biotronik, Inc.
Cardiovascular · 95d
Cleared May 19, 2023
iLet® ACE Pump
K223846 · QFG
Beta Bionics, Inc.
Chemistry · 150d