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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
150097–150120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 1985
ENTERNAL FEEDING TUBE-POLYURETHANE EF504
K844175 · KNT
Exco, Inc.
Gastroenterology & Urology · 69d
Cleared Jan 02, 1985
ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403
K844203 · KNT
Exco, Inc.
Gastroenterology & Urology · 64d
Cleared Jan 02, 1985
ELECTROCARDIOGRAPH ELECTRODE
K844335 · DRX
Meditect
Cardiovascular · 56d
Cleared Jan 02, 1985
CONTOUR ELECTRODE
K844345 · DRX
Heuristic Medical Systems, Inc.
Cardiovascular · 54d
Cleared Jan 02, 1985
SKIASCOPIC RACKS
K844364 · HMH
Luneau Laboratories
Ophthalmic · 50d
Cleared Jan 02, 1985
COLOR VISION TESTERS
K844365 · HIT
Luneau Laboratories
Ophthalmic · 50d
Cleared Jan 02, 1985
UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK
K844503 · FAP
Epcom Medical Systems, Inc.
Gastroenterology & Urology · 43d
Cleared Jan 02, 1985
ENDOSCOPIC MANUAL AIR INSUFFLATOR
K844689 · FCX
Jayco Pharmaceuticals
Gastroenterology & Urology · 30d
Cleared Jan 02, 1985
ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT
K844690 · FCL
Jayco Pharmaceuticals
Gastroenterology & Urology · 30d
Cleared Jan 02, 1985
ENDOSCOPIC ASPIRATION CATHETER SET
K844691 · OCX
Jayco Pharmaceuticals
Gastroenterology & Urology · 30d
Cleared Jan 02, 1985
TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA
K844752 · DTB
Mansfield Scientific, Inc.
Cardiovascular · 27d
Cleared Jan 02, 1985
KANGAROO ACCESS II ENTERAL FEEDING CONTAINER
K844789 · KNT
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 23d
Cleared Jan 02, 1985
ELECATH GALLAGHER MAPPING CATHETER
K844805 · DRF
Electro-Catheter Corp.
Cardiovascular · 22d
Cleared Jan 01, 1985
LUNG AEROSOL UNIT
K800023 · CAF
Cadema Medical Products, Inc.
General Hospital · 1821d
Cleared Jan 01, 1985
UNKNOWN
K828543
General Electric Co.
Radiology · 775d
Cleared Dec 29, 1984
FILTER PURGE LINE EC-FPL SERIES
K833644 · DTL
Gish Biomedical, Inc.
Cardiovascular · 439d
Cleared Dec 28, 1984
PHOTIC STIMULATOR TM-3030-70
K842964 · GWE
Tracor Northern, Inc.
Neurology · 154d
Cleared Dec 28, 1984
SERVO VENTILATOR 900D SIEMENS-ELEMA AB
K844912 · CBK
Siemens Elema AB
Anesthesiology · 10d
Cleared Dec 27, 1984
CORDIS ENCOR ATRIAL LEAD
K811259 · DTB
Cordis Corp.
Cardiovascular · 1331d
Cleared Dec 27, 1984
EBNA ACIF KIT
K840417 · LLM
Litton Bionetics
Microbiology · 331d
Cleared Dec 27, 1984
ANTI-LEU-4 FITC LYSIN C BUFFER
K842218 · LIZ
Bd Becton Dickinson Vacutainer...
Hematology · 206d
Cleared Dec 27, 1984
VENOUS RESERVOIR-BMR-1500-HARD SHELL
K842373 · DTP
American Bentley
Cardiovascular · 195d
Cleared Dec 27, 1984
RT-50
K843320 · IYO
General Electric Co.
Radiology · 125d
Cleared Dec 27, 1984
ECG PATIENT MONITOR
K843376 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 121d