Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
143785–143808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 1986
INTERNATIONAL TOTAL HIP SYSTEM
K862225 · JDI
Richards Medical Co., Inc.
Orthopedic · 30d
Cleared Jul 11, 1986
TDX BENZODIAZEPINES
K862250 · JXM
Abbott Laboratories
Toxicology · 29d
Cleared Jul 11, 1986
ALTERNATE SIZE E-Z-PACE ELECTRODE
K862298 · DRO
Medtronic Vascular
Cardiovascular · 24d
Cleared Jul 11, 1986
SENTEC LASER GUIDE LINE, MODEL SGL-05
K862340 · IZW
Sentec Corp.
Radiology · 21d
Cleared Jul 11, 1986
VACUUM HANDLE MODEL I/A - 1
K862343 · HQE
Cutler Medical Instruments
Ophthalmic · 21d
Cleared Jul 11, 1986
ENDOTRACHEAL TUBE, ACCESSORY
K862347 · BTR
Sheridan Catheter Corp.
Anesthesiology · 21d
Cleared Jul 11, 1986
EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95
K862403 · DKB
Diagnostic Systems
Toxicology · 15d
Cleared Jul 11, 1986
SNAP-ON TORQUER
K862409 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 16d
Cleared Jul 11, 1986
PRECEPT CEFTAZIDIME
K862446 · JWY
Austin Biological Laboratories
Microbiology · 14d
Cleared Jul 11, 1986
MASUNAGA OPTICAL MANUFACTURING
K862502 · HQZ
South West Intl., Inc.
Ophthalmic · 10d
Cleared Jul 11, 1986
KOELN OPTIK
K862503 · HQZ
South West Intl., Inc.
Ophthalmic · 10d
Cleared Jul 11, 1986
RITCH TRABECULOPLASTY LASER LENS
K862512 · HKS
Ocular Instruments, Inc.
Ophthalmic · 10d
Cleared Jul 11, 1986
BAUSCH & LOMB CSL-1000 SLIT LAMP
K862515 · HJO
Bausch & Lomb, Inc.
Ophthalmic · 10d
Cleared Jul 11, 1986
BAUSCH & LOMB OSL-2000 SLIT LAMP
K862516 · HJO
Bausch & Lomb, Inc.
Ophthalmic · 10d
Cleared Jul 11, 1986
BAUSCH & LOMB PSL-3000 SLIT LAMP
K862520 · HJO
Bausch & Lomb, Inc.
Ophthalmic · 10d
Cleared Jul 11, 1986
BAUSCH & LOMB GR-3 REFRACTOR
K862521 · HKO
Bausch & Lomb, Inc.
Ophthalmic · 10d
Cleared Jul 11, 1986
SENTRY BREAKWAY NECK STRAP
K862538 · DZB
Ormco Corp.
Dental · 9d
Cleared Jul 11, 1986
PRECEPT CEFTIZOXIME
K862560 · JWY
Austin Biological Laboratories
Microbiology · 8d
Cleared Jul 11, 1986
KODAK M35A X-OMAT PROCESSOR
K862595 · IXW
Eastman Kodak Company
Radiology · 3d
Cleared Jul 10, 1986
ARF-1500 CONTINUOUS VENTILATOR
K860798 · CBK
Medimex, Inc.
Anesthesiology · 128d
Cleared Jul 10, 1986
MASTER KIT B
K861142 · LRP
Pro-Lab, Inc.
General & Plastic Surgery · 106d
Cleared Jul 10, 1986
ACS CORONARY GUIDING CATHETER
K861236 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 99d
Cleared Jul 10, 1986
MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445
K861472 · FKQ
National Medical Care, Medical...
Gastroenterology & Urology · 79d
Cleared Jul 10, 1986
ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7
K861536 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 77d