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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
163537–163560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1981
HEMOTHERM MODEL 400
K811742 · DWJ
Cincinnati Sub-Zero
Cardiovascular · 55d
Cleared Aug 13, 1981
NEIA PAP ENZYMEIMMUNOASSAY
K811757 · JFH
New England Immunology Assoc.
Immunology · 52d
Cleared Aug 13, 1981
SENSITITIRE AP60
K811765 · JSS
Gibco Laboratories Life Technologies,...
Microbiology · 52d
Cleared Aug 13, 1981
ADAPTAID LEAD ADAPTER, #365-17
K811920 · DTD
Intermedics, Inc.
Cardiovascular · 42d
Cleared Aug 13, 1981
DSS 500
K811934 · KPR
Philips Medical Systems (Cleveland),...
Radiology · 38d
Cleared Aug 13, 1981
KENL-ECG-3
K811949 · DPS
Suzuken Co., Ltd.
Cardiovascular · 37d
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