FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

175,468 results

70561–70584 of 175,468

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

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

Cleared Oct 17, 2003

RADIUS COUGAR WIRE

Radius Medical Technologies, Inc.

Cardiovascular · 30d

Cleared Oct 17, 2003

NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210

Dolphin Medical, Inc.

Anesthesiology · 25d

Cleared Oct 16, 2003

MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND...

Mahe Intl., Inc.

Ear, Nose, Throat · 212d

Cleared Oct 16, 2003

ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294

General Hospital · 199d

Cleared Oct 16, 2003

UUHC REPROCESSED COMPRESSION SLEEVE DEVICES

University of Utah Hospitals and Clinics

Cardiovascular · 184d

Cleared Oct 16, 2003

STRYKER FLEXIBLE URETEROSCOPE

Stryker Endoscopy

Gastroenterology & Urology · 177d

Cleared Oct 16, 2003

POWDER FREE LATEX EXAM GLOVES

Tan Sin Lian Industries Sdn. Bhd.

General Hospital · 171d

Cleared Oct 16, 2003

EASYGLUCO, MODEL IGM0002

American Healthcare, Inc.

Chemistry · 156d