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: 2026–2026 ×
1,922 results
1585–1608 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Feb 13, 2026
Argos Infinity (Rev. 1.0)
K253092 · DXG
Retia Medical Systems, Inc.
Cardiovascular · 143d
Cleared Feb 13, 2026
NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712,...
K253089 · DXQ
Shenzhen Best Electronics Co., Ltd.
Cardiovascular · 143d
Cleared Feb 13, 2026
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K252891 · DXT
Bayer Medical Care, Inc.
General Hospital · 155d
Cleared Feb 13, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L,...
K252685 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 171d
Cleared Feb 13, 2026
PreOp v3
K252565 · OLX
Clouds of Care
Neurology · 183d
Cleared Feb 13, 2026
Armada™ 14 NC PTA Catheter
K252512 · LIT
Abbott Medical
Cardiovascular · 186d
Cleared Feb 13, 2026
Wearable Breast Pump (Model W2)
K252422 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 196d
Cleared Feb 13, 2026
Wearable Breast Pump (Model W12)
K252420 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 196d
Cleared Feb 13, 2026
Endomina EZFuse system
K252400 · OCW
Endo Tools Therapeutics S.A.
Gastroenterology & Urology · 197d
Cleared Feb 13, 2026
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01)
K251928 · GEH
Medinice S.A.
Cardiovascular · 235d
Cleared Feb 13, 2026
cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
K251852 · OWN
VPIX Medical, Inc.
General & Plastic Surgery · 241d
Cleared Feb 13, 2026
STAR RF Ablation System
K251802 · GXI
Merit Medical Systems, Inc.
Neurology · 246d
Cleared Feb 13, 2026
VELO Respiratory Test
K251742 · QOF
Lex Diagnostics Limited
Microbiology · 252d
Cleared Feb 13, 2026
Babyleo TN500
K251619 · FMZ
Dr?gerwerk AG & Co KGaA
General Hospital · 262d
Cleared Feb 13, 2026
Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
K251581 · DXN
Shenzhen Hingmed Medical Instrument...
Cardiovascular · 266d
Cleared Feb 13, 2026
PreemptiveAI Clinical SDK
K250233 · DXH
Measure Labs, Inc. (Dba Preemptiveai,...
Cardiovascular · 382d
Cleared Feb 13, 2026
Contour Light (CL-100)
K243854 · OLI
Contour Research, LLC
General & Plastic Surgery · 424d
Cleared Feb 12, 2026
Saberscope™ Laparoscope (SAS-A-536L)
K260177 · GCJ
Xenocor, Inc.
General & Plastic Surgery · 22d
Cleared Feb 12, 2026
L12 LED Light Source with AIM
K260108 · OWN
Stryker Endoscopy
General & Plastic Surgery · 29d
Cleared Feb 12, 2026
LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)
K254007 · OHS
SZ KKS Silicone&Electronic Co., Ltd.
General & Plastic Surgery · 59d
Cleared Feb 12, 2026
IMAGE1 (TC400US)
K253972 · OWN
Karl Storz SE & CO. KG
General & Plastic Surgery · 63d
Cleared Feb 12, 2026
ISE indirect K for Gen.2
K253491 · CEM
Roche Diagnostics
Chemistry · 111d
Cleared Feb 12, 2026
Glucose HK Gen.3
K253490 · CFR
Roche Diagnostics
Chemistry · 111d
Cleared Feb 12, 2026
Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
K253381 · OLO
Medtronic Navigation, Inc.
Orthopedic · 135d