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

70993–71016 of 176,076

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

Cleared Nov 04, 2003

HYDRAGEL CSF ISOFOCUSING KITS

Immunology · 25d

Cleared Nov 04, 2003

COLIBRI DISPOSABLE VITRECTOMY CUTTER

Microworld Medical Instruments, Inc.

Ophthalmic · 12d

Cleared Nov 03, 2003

ATAC HEMOGLOBIN A1C REAGENT KIT

Clinical Data, Inc.

Chemistry · 216d

Cleared Nov 03, 2003

OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM

Cleared Nov 03, 2003

EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE

Edwards Lifesciences, LLC

Cardiovascular · 132d

Cleared Nov 03, 2003

Coltene/Whaledent GmbH & Co. KG

Cleared Nov 03, 2003

BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT)

Lin-Zhi International, Inc.

Toxicology · 59d

Cleared Nov 03, 2003

CRYOCHECK WEAK LUPUS POSITIVE CONTROL

Precision Biologic

Hematology · 55d

Cleared Nov 03, 2003

SPI EASY DENTAL IMPLANT PROTECTIVE CAP

Thommen Medical AG

Cleared Oct 31, 2003

DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS

Danmar Products, Inc.

Neurology · 743d

Cleared Oct 31, 2003

SUN-RAIN ULTRASONIC THERAPY, SU-100

Sun-Rain System Corp.

Physical Medicine · 331d

Cleared Oct 31, 2003

KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

Kodon(Tianjin)Electronic&Electrical...

Cardiovascular · 270d

Cleared Oct 31, 2003

NIPRO DISPOSABLE SYRINGES

Nipro Medical Corp.

General Hospital · 240d

Cleared Oct 31, 2003

MERCATOR HEALTHCARE MALE LATEX CONDOM

Mercator Healthcare , Ltd.

Obstetrics & Gynecology · 184d

Cleared Oct 31, 2003

JABES ELECTRONIC STETHOSCOPE

Gs Technology Co., Ltd.

Cardiovascular · 177d

Cleared Oct 31, 2003

Spinerx Technology

Physical Medicine · 137d

Cleared Oct 31, 2003

CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD

Wrightmedicaltechnologyinc

Orthopedic · 128d

Cleared Oct 31, 2003

AUDICOR UPGRADE SYSTEM

Inovise Medical, Inc.

Cardiovascular · 109d

Cleared Oct 31, 2003

ZOLL M SERIES NIBP OPTION

Zoll Medical Corp

Cardiovascular · 92d

Cleared Oct 31, 2003

BONE CEMENT RADIO-OPACIFIER

Neurology · 88d

Cleared Oct 31, 2003

PLUS PIVOT LINK UNIVERSAL SYSTEM

Spine Vision, Inc.

Orthopedic · 88d

Cleared Oct 31, 2003

GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET

Cardiovascular · 86d

Cleared Oct 31, 2003

HEDROCEL VERTEBRAL BODY REPLACEMENT

Orthopedic · 77d

Cleared Oct 31, 2003

DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111

Dade Behring, Inc.

Chemistry · 72d