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

70561–70584 of 176,076

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

Cleared Dec 17, 2003

BAYER RAPIDLAB 1200 SYSTEM

Bayer Healthcare, LLC

Chemistry · 212d

Cleared Dec 17, 2003

B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)

Disc-O-Tech Medical Technologies, Ltd.

Orthopedic · 140d

Cleared Dec 17, 2003

MODIFICATION TO: NUCAMMA RX

Is2 Research, Inc.

Radiology · 100d

Cleared Dec 17, 2003

PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE

Wrp Asia Pacific Sdn. Bhd.

General Hospital · 86d

Cleared Dec 17, 2003

STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE...

Gastroenterology & Urology · 86d

Cleared Dec 17, 2003

PHOENIX INFANT RADIANT WARMER, MODEL 100NWS

International Hospital Supply Co.

General Hospital · 79d

Cleared Dec 17, 2003

CONDUCTIVE EEG ELECTROLYTE

Compumedics USA, Ltd.

Neurology · 79d

Cleared Dec 17, 2003

(MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES

Bernard Technologies, Inc.

General Hospital · 72d

Cleared Dec 17, 2003

GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL

Usa Instruments, Inc.

Radiology · 72d

Cleared Dec 17, 2003

MEDICAL IMAGE DIGITIZER, MODEL 2908

Radiology · 28d

Cleared Dec 17, 2003

VENTURI PHACO PACK

Bausch & Lomb, Inc.

Ophthalmic · 26d

Cleared Dec 17, 2003

MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM

Centerpulse Orthopedics, Inc.

Orthopedic · 26d

Cleared Dec 17, 2003

General & Plastic Surgery · 26d

Cleared Dec 17, 2003

SET GRI-FILL 2.0-1 WAY

Laboratorios Grifols, S.A.

General Hospital · 23d

Cleared Dec 17, 2003

CONTOUR-FLEX VALVE AND SHUNT SYSTEM

Integra Neurosciences Implants S.A.

Neurology · 22d

Cleared Dec 17, 2003

LIGHTCYCLER INSTRUMENT VERSION 1.2

Roche Diagnostics Corp.

Chemistry · 19d

Cleared Dec 17, 2003

PELVIC ARRAY COIL

Usa Instruments, Inc.

Radiology · 16d

Cleared Dec 16, 2003

Sra Developments, Ltd.

General & Plastic Surgery · 133d

Cleared Dec 16, 2003

AESKULISA ANA 8PRO

Immunology · 127d

Cleared Dec 16, 2003

EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION

Axon Systems, Inc.

Neurology · 103d

Cleared Dec 16, 2003

THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM

Thai Nippon Rubber Industry Co., Ltd.

Obstetrics & Gynecology · 90d

Cleared Dec 16, 2003

THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003

Cardiovascular · 85d

Cleared Dec 16, 2003

GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)

Gemore Technology Co, Ltd.

Neurology · 82d

Cleared Dec 16, 2003

HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP

Harvard Clinical Technology

General Hospital · 78d