FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results

134353–134376 of 175,820

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

Cleared Sep 30, 1988

Intl. Immunoassay Laboratories, Inc.

Chemistry · 63d

Cleared Sep 30, 1988

RAPIDTEST-HCG (TM)

Synbiotics Corp.

Chemistry · 60d

Cleared Sep 30, 1988

MULTI-CARE CHAIR

Mid-Canada Medical

Physical Medicine · 56d

Cleared Sep 30, 1988

AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT

Amerimed US Corp.

Neurology · 44d

Cleared Sep 30, 1988

HORIZON ORTHOPEDIC PIN PROTECTOR

Horizon Medical, Inc.

Orthopedic · 39d

Cleared Sep 30, 1988

#400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY

Anesthesiology · 38d

Cleared Sep 30, 1988

PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER

Codman & Shurtleff, Inc.

Neurology · 38d

Cleared Sep 30, 1988

ATS BLOOD RECOVERY BAG

Atrium Medical Corp.

Anesthesiology · 35d

Cleared Sep 30, 1988

DAS SPORT PUMP(TM)

D.A. Schulman, Inc.

Physical Medicine · 32d

Cleared Sep 30, 1988

RESUSCITATION BAG EXHALATION FILTER

Intertech Resources, Inc.

General Hospital · 32d

Cleared Sep 30, 1988

World Precision Instruments, Inc.

Neurology · 17d

Cleared Sep 30, 1988

MEDIUM 199 W/EBSS (CATALOG NO. 200-2037)

Pathology · 11d

Cleared Sep 30, 1988

Dyna Industries, Inc.

Physical Medicine · 10d

Cleared Sep 29, 1988

General Hospital · 233d

Cleared Sep 29, 1988

Zinnanti Surgical Instruments, Inc.

Obstetrics & Gynecology · 136d

Cleared Sep 29, 1988

DRY COMFORT UNDERGARMENT

Health Tec, Inc.

Gastroenterology & Urology · 108d

Cleared Sep 29, 1988

PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535

Medical Devices, Inc.

Neurology · 80d

Cleared Sep 29, 1988

PROGEL(TM), MODELS 8630 AND 8635

Medical Devices, Inc.

Neurology · 80d

Cleared Sep 29, 1988

PULMONARY FORCED FLOW SYSTEM (PUFFS)

Medical Associated Services, Inc.

Anesthesiology · 73d

Cleared Sep 29, 1988

MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND

Gastroenterology & Urology · 72d

Cleared Sep 29, 1988

SKIFA, PLASTIC DISPOSABLE SYRINGE

P.T. Setio Harto , Ltd.

General Hospital · 59d

Cleared Sep 29, 1988

HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED

Radiology · 57d

Cleared Sep 29, 1988

BARD BIOPSY NEEDLE GUIDANCE DEVICE

C.R. Bard, Inc.

Gastroenterology & Urology · 51d

Cleared Sep 29, 1988

ACCUFLO UF CONTROL MODULE NO. 74-0100-3

National Medical Care, Medical...

Gastroenterology & Urology · 44d