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
143209–143232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 10, 1986
ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5
K861537 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 77d
Cleared Jul 10, 1986
COTTON FILLED GAUZE SPONGES 2 X 2
K861727 · EFN
Cross Country Paper Products Corp.
Dental · 65d
Cleared Jul 10, 1986
CURITY VENOUS CATHETERIZATION KIT
K861828 · DQY
The Kendal Co.
Cardiovascular · 59d
Cleared Jul 10, 1986
CURITY CENTRAL VENOUS CATHETER
K861829 · DQY
The Kendal Co.
Cardiovascular · 59d
Cleared Jul 10, 1986
515A NEO-TRAK NEONATAL MONITOR
K861861 · KLK
Ge Medical Systems Information...
Anesthesiology · 57d
Cleared Jul 10, 1986
ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER
K861916 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 52d
Cleared Jul 10, 1986
V-MARC 88A COMPUTER
K862089 · KQH
V.Marc, A Div. of Pictorial, Inc.
Hematology · 38d
Cleared Jul 10, 1986
MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD
K862257 · DTB
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jul 10, 1986
MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD
K862258 · DTB
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jul 10, 1986
MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD
K862259 · DTB
Intermedics, Inc.
Cardiovascular · 27d
Cleared Jul 10, 1986
FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR
K862318 · JPK
Fisher Scientific Co., LLC
Hematology · 22d
Cleared Jul 10, 1986
SUCTION T CONNECTOR
K862434
Acutronic Medical Systems AG
Anesthesiology · 14d
Cleared Jul 10, 1986
MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS
K862443 · DTB
Medtronic Vascular
Cardiovascular · 14d
Cleared Jul 10, 1986
RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC
K862468 · IMJ
Rich-Mar Corp.
Physical Medicine · 10d