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

141049–141072 of 175,230

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

Cleared Jan 21, 1987

WELLCOZYME ROTAVIRUS WZ01

Wellcome Diagnostics

Microbiology · 267d

Cleared Jan 21, 1987

NOVOPEN SYSTEM (INSULIN SYRINGE)

Squibb-Novo, Inc.

General Hospital · 264d

Cleared Jan 21, 1987

CHALLENGE ORTHODONTIC BONDING ADHESIVE

Cleared Jan 21, 1987

AMYLASE REAGENT

Trace Scientific , Ltd.

Chemistry · 79d

Cleared Jan 21, 1987

BECKMAN EPSILON(TM) PROLACTIN TEST KIT

Beckman Instruments, Inc.

Chemistry · 70d

Cleared Jan 21, 1987

PSI AMYLASE REAGENT

Pointe Scientific, Inc.,

Chemistry · 70d

Cleared Jan 21, 1987

IL TEST 84668-15, FACTOR VIII CONTROL PLASMA

Instrumentation Laboratory CO

Hematology · 69d

Cleared Jan 21, 1987

BT HYPODERMIC SYRINGE

Baron Technologies, Inc.

General Hospital · 63d

Cleared Jan 21, 1987

Grandcor Medical Systems

Physical Medicine · 62d

Cleared Jan 21, 1987

PENOX HOSPITAL BED

Penox Technologies, Inc.

General Hospital · 50d

Cleared Jan 21, 1987

UNSCENTED MENSTRUAL PAD

Procter & Gamble Mfg. Co.

Obstetrics & Gynecology · 50d

Cleared Jan 21, 1987

MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES

Cleared Jan 21, 1987

STRATO(R) PCA INFUSER

Strato Medical Corp.

General Hospital · 43d

Cleared Jan 21, 1987

RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR

Tactilitics, Inc.

General Hospital · 43d

Cleared Jan 21, 1987

OSI PAPOOSE BOARD

Orthopedic Systems, Inc.

General & Plastic Surgery · 40d

Cleared Jan 21, 1987

FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY

Pointe Scientific, Inc.,

Chemistry · 40d

Cleared Jan 21, 1987

WEIGHMOBILE, IN BED PATIENT WEIGHING SCALE

Dittmar and Penn Corp.

General Hospital · 34d

Cleared Jan 21, 1987

ARROW XT POWERED WHEELCHAIR

Physical Medicine · 23d

Cleared Jan 21, 1987

AMG + MED LANCET

Can-Am Surgical Corp.

General & Plastic Surgery · 19d

Cleared Jan 21, 1987

AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460

American Research Products Co.

Chemistry · 16d

Cleared Jan 21, 1987

MCD SPECIALTY BRAND NEEDLE COUNTERS

Medical Concepts Development, Inc.

General & Plastic Surgery · 16d

Cleared Jan 21, 1987

TOSHIBA, SMIT ROENTGEN

North American Imaging, Inc.

Radiology · 13d

Cleared Jan 21, 1987

LEAD APRON CADDY

Orthopedic Systems, Inc.

Radiology · 12d

Cleared Jan 20, 1987

UROCUT BIOPSY NEEDLE

Meadox Surgimed, Inc.

Gastroenterology & Urology · 291d