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

71161–71184 of 176,076

Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery

Cleared Oct 21, 2003

GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER

Gonotec Gesellschaft Fuer Mess-Und...

Chemistry · 57d

Cleared Oct 21, 2003

NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE

Orthosoft, Inc.

Neurology · 29d

Cleared Oct 21, 2003

GE LOGIQ 5 PRO OR EXPERT

General Electric Co.

Radiology · 27d

Cleared Oct 21, 2003

GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM

Hmd Biomedical, Inc.

Chemistry · 27d

Cleared Oct 21, 2003

S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR

Micro Current Technology, Inc.

Neurology · 13d

Cleared Oct 20, 2003

GC America, Inc.

Cleared Oct 20, 2003

GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD...

Bionostics, Inc.

Chemistry · 40d

Cleared Oct 20, 2003

EPT CERTAINTY PREGNANCY TEST

Chemistry · 28d

Cleared Oct 20, 2003

MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME

Ciba Vision Corporation

Ophthalmic · 26d

Cleared Oct 20, 2003

1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES

Cleared Oct 20, 2003

ITI SYNOCTA MESO ABUTMENTS

Cleared Oct 20, 2003

HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM

Hitachi Medical Systems America, Inc.

Radiology · 13d

Cleared Oct 17, 2003

EZ SPLINT & EZ SPLINT PM

Power Products, Inc.-Splintek

Cleared Oct 17, 2003

MODEL 3100 WRISTOX PULSE OXIMETER

Nonin Medical, Inc.

Anesthesiology · 228d

Cleared Oct 17, 2003

Ivoclar Vivadent, Inc.

Cleared Oct 17, 2003

VIEWMATE ULTRASOUND IMAGING SYSTEM

Radiology · 197d

Cleared Oct 17, 2003

AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST

Amedica Biotech, Inc.

Toxicology · 157d

Cleared Oct 17, 2003

ROCHE DIAGNOSTICS OMNI S ANALYZER

Roche Diagnostics Corp.

Chemistry · 81d

Cleared Oct 17, 2003

Nakanishi, Inc.

Cleared Oct 17, 2003

MAXTER STERILE POWDER FREE SURGICAL GLOVES

Maxter Glove Manufacturing Sdn Bhd

General Hospital · 65d

Cleared Oct 17, 2003

SHANGHAI GIANTMAX POWDERED CLEAR VINYL EXAMINATION GLOVES

Shanghai Giantmax Plastic Product Corp.

General Hospital · 43d

Cleared Oct 17, 2003

SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES

Shanghai Giantmax Plastic Product Corp.

General Hospital · 43d

Cleared Oct 17, 2003

MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR

Albert Browne , Ltd.

General Hospital · 38d

Cleared Oct 17, 2003

MICROGENICS CYCLOSPORINE CONTROL KIT

Microgenics Corp.

Chemistry · 36d