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
162697–162720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1981
KENL-ECG
K811950 · DPS
Suzuken Co., Ltd.
Cardiovascular · 37d
Cleared Aug 13, 1981
CP-625 SEE-THRU FILM CHANGER
K811967 · KPX
Philips Medical Systems (Cleveland),...
Radiology · 34d
Cleared Aug 13, 1981
DUAL PEDESTAL TABLE
K811969 · KXJ
Philips Medical Systems (Cleveland),...
Radiology · 34d
Cleared Aug 13, 1981
AP X-RAY TUBE ANGULATION DEVICE
K811970 · IYB
Philips Medical Systems (Cleveland),...
Radiology · 34d
Cleared Aug 13, 1981
CORDIS DUCOR PTR SYSTEM
K811971 · DQY
Cordis Corp.
Cardiovascular · 34d
Cleared Aug 13, 1981
GATOR DRAPES
K811996 · KKX
The Anspach Effort, Inc.
General Hospital · 29d
Cleared Aug 13, 1981
XEROX 128 CASSETTE CHANGER
K812024 · KPX
Xerox Medical Systems
Radiology · 24d
Cleared Aug 13, 1981
THE LYMAN BATHCHAIR
K812033 · ILJ
The Lyman Bathchair Corp.
Physical Medicine · 24d
Cleared Aug 13, 1981
SPHGOMOMANOMETER
K812059 · DXN
Med-Tek Corp.
Cardiovascular · 23d
Cleared Aug 13, 1981
BI-ASO SLIDE TEST
K812060 · GTQ
Biologics Intl., Inc.
Microbiology · 23d
Cleared Aug 13, 1981
POLI-AXIAL KNEE CAGE
K812064 · ITM
Generation II Orthotics, Inc.
Physical Medicine · 23d
Cleared Aug 13, 1981
KANAMYCIN DISK
K812082 · JTO
Remel Co.
Microbiology · 22d
Cleared Aug 13, 1981
BILE DISK
K812083 · JTO
Remel Co.
Microbiology · 22d
Cleared Aug 13, 1981
SPS DISK
K812084 · JTO
Remel Co.
Microbiology · 22d
Cleared Aug 13, 1981
EA 65
K812086 · HZJ
Surgipath
Pathology · 22d
Cleared Aug 13, 1981
EA 50
K812087 · HZJ
Surgipath
Pathology · 22d
Cleared Aug 13, 1981
COBE HEAT EXCHANGER RESERVOIR MODULE
K812093 · DTR
Cobe Laboratories, Inc.
Cardiovascular · 20d
Cleared Aug 13, 1981
AIRCAST PNEUMATIC KNEE BRACE
K812094 · ITQ
Aircast, Inc.
Physical Medicine · 20d
Cleared Aug 13, 1981
CASH ORTHOSIS
K812099 · IPY
David Hendricks, C.P.O.
Physical Medicine · 20d
Cleared Aug 13, 1981
ESOPHAGEAL MOTILITY APPARATUS
K812103 · FFX
Honeywell, Inc.
Gastroenterology & Urology · 20d
Cleared Aug 13, 1981
GILCHEM CREATININE REAGENT
K812109 · CGX
Gilford Diagnostics
Chemistry · 17d
Cleared Aug 13, 1981
GILCHEM CALCIUM REAGENT
K812110 · CIC
Gilford Diagnostics
Chemistry · 17d
Cleared Aug 13, 1981
MARRIA-HPRL RIA KIT
K812112 · CFT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 17d
Cleared Aug 13, 1981
COAT-A-COUNT DIGITOXIN RIA KIT
K812129 · DPG
Diagnostic Products Corp.
Toxicology · 17d