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

74881–74904 of 176,076

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

Cleared Oct 01, 2002

PMX DISPOSABLE BAG MASK RESUSCITATOR

Allied Healthcare Products, Inc.

Anesthesiology · 295d

Cleared Oct 01, 2002

AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

Bayer Diagnostics Corp.

Immunology · 203d

Cleared Oct 01, 2002

ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865

Fortune Medical Instrument Corp.

Gastroenterology & Urology · 175d

Cleared Oct 01, 2002

BIOLOGICAL SOUND MONITOR (BSM) SENSOR

Cardiovascular · 152d

Cleared Oct 01, 2002

UNITY NETWORK ID

General Electric Medical Systems...

Cardiovascular · 148d

Cleared Oct 01, 2002

Pie Medical Imaging BV

Cardiovascular · 145d

Cleared Oct 01, 2002

NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES

General & Plastic Surgery · 90d

Cleared Oct 01, 2002

Cardiovascular · 77d

Cleared Oct 01, 2002

LIVESIRE ELECTROPHYSIOLOGY CATHETER

St Jude Medical

Cardiovascular · 71d

Cleared Oct 01, 2002

SPIFE LD-12 KIT, MODEL 3338

Helena Laboratories

Chemistry · 67d

Cleared Oct 01, 2002

SNIFF POSITION PILLOWS/POPITZ PILLOWS

Aeolus International Corporation

Ear, Nose, Throat · 22d

Cleared Sep 30, 2002

MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

Chroma Vision Medical Systems, Inc.

Pathology · 447d

Cleared Sep 30, 2002

BIO-RAD PLATELIA TOXO IGM TMB

Microbiology · 315d

Cleared Sep 30, 2002

BIO-RAD PLATELIA TOXO IGG TMB

Microbiology · 315d

Cleared Sep 30, 2002

WHISPER WEAR BREAST PUMP

Obstetrics & Gynecology · 90d

Cleared Sep 30, 2002

LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D

Fischer Industries, Inc.

Radiology · 90d

Cleared Sep 30, 2002

EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET

Exelint Intl. Co.

General Hospital · 69d

Cleared Sep 30, 2002

SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST

Spectral Diagnostics, Inc.

Chemistry · 68d

Cleared Sep 30, 2002

CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518

Immunicon Corp.

Hematology · 62d

Cleared Sep 30, 2002

LDL CHOLESTEROL (AUTOMATED)

Jas Diagnostics, Inc.

Chemistry · 62d

Cleared Sep 30, 2002

FASTPACK TESTOSTERONE CALIBRATOR

Chemistry · 61d

Cleared Sep 30, 2002

HARMONY INR MONITORING SYSTEM

Hematology · 26d

Cleared Sep 30, 2002

GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT

Abbott Laboratories, Inc.

General Hospital · 14d

Cleared Sep 27, 2002

MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE

Radiology · 308d