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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

174,955 results

70033–70056 of 174,955

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

Cleared Oct 21, 2003

BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES...

Biolab Equipment Canada , Ltd.

Gastroenterology & Urology · 260d

Cleared Oct 21, 2003

LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER...

Cliniqa Corporation

Chemistry · 106d

Cleared Oct 21, 2003

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY...

Microbiology · 97d

Cleared Oct 21, 2003

ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM

Medtronic Vascular

Cardiovascular · 85d

Cleared Oct 21, 2003

HEMEDEX CRANIAL BOLT MODELS, 3601, 3602

Hemedex Incorporated

Neurology · 84d

Cleared Oct 21, 2003

THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT

BioHorizons Implant Systems, Inc.

Cleared Oct 21, 2003

MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI

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