FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2026–2026 ×
1,642 results
889–912 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 02, 2026
SMART M-CELL PRP Concentration System
K250516 · QBV
Miracell Co., Ltd.
Hematology · 405d
Cleared Apr 01, 2026
Arm Blood Pressure Monitor Models: ARM-30C+
K260276 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 62d
Cleared Apr 01, 2026
Hyaluronic Acid Vaginal Suppository (HA 5 mg)
K260007 · NUC
Hudi Pharma Srl
Obstetrics & Gynecology · 89d
Cleared Apr 01, 2026
Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL,...
K254225 · DXN
Shenzhen HanHan Technology Co., Ltd.
Cardiovascular · 93d
Cleared Apr 01, 2026
CoLumbo C-Spine
K254015 · QIH
Smart Soft Healthcare AD
Radiology · 107d
Cleared Apr 01, 2026
enHAnce PEEK Bunion System
K253718 · HRS
Nvision Biomedical Technologies, Inc.
Orthopedic · 128d
Cleared Apr 01, 2026
RM Electrode (RMH 25-01)
K253586 · HLZ
Retmap, Inc.
Ophthalmic · 135d
Cleared Apr 01, 2026
Medical Imaging Calibration Feature (MICF)
K253582 · SHN
Apple, Inc.
Radiology · 135d
Cleared Apr 01, 2026
Synchrony
K253473 · DQK
Stereotaxis, Inc.
Cardiovascular · 173d
Cleared Apr 01, 2026
Prana System
K253405 · GEI
Prana Surgical
General & Plastic Surgery · 183d
Cleared Apr 01, 2026
GentleCath Air for Men
K252943 · EZD
Convatec Limited
Gastroenterology & Urology · 198d
Cleared Apr 01, 2026
GEM Flex Coil 16-L Array, 3.0T Receive Only
K252876 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 203d
Cleared Apr 01, 2026
Polywin Safety (14G x 51mm
K252513 · FOZ
Poly Medicure Limited
General Hospital · 233d
Cleared Apr 01, 2026
MOD-C
K242303 · ODP
Orthomod, LLC
Orthopedic · 604d
Cleared Mar 28, 2026
CO2 Laser System
K260257 · GEX
Sanhe Meditech Co., Ltd.
General & Plastic Surgery · 59d
Cleared Mar 28, 2026
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
K252360 · SAT
Anumana, Inc.
Cardiovascular · 242d
Cleared Mar 27, 2026
S-scan Open (100001800)
K260746 · LNH
Esaote, S.P.A.
Radiology · 21d
Cleared Mar 27, 2026
VyPlate™ Anterior Cervical Plate System
K260697 · KWQ
Vy Spine, LLC
Orthopedic · 23d
Cleared Mar 27, 2026
SF Push-in Anchor
K260294 · MAI
Surgical Fusion Technologies GmbH
Orthopedic · 57d
Cleared Mar 27, 2026
Strauss Surgical cystoscope, hysteroscope and accessories Instruments
K260271 · FAJ
American Medical Endoscopy, Inc.
Gastroenterology & Urology · 58d
Cleared Mar 27, 2026
AVENTIX PFX System (PFX01)
K260255 · GEI
Aventix Medical, Inc.
Ear, Nose, Throat · 58d
Cleared Mar 27, 2026
SYMPHONY Navigation Ready Instruments
K260240 · OLO
Medos International SARL
Orthopedic · 60d
Cleared Mar 27, 2026
MDx-Chex for BCP
K260041 · PMN
Streck, LLC
Microbiology · 80d
Cleared Mar 27, 2026
CyClean Cord
K254239 · MVL
SS GLOBAL
Dental · 88d