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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

174,955 results

69865–69888 of 174,955

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

Cleared Nov 05, 2003

VIATRONIX V3D VASCULAR, REVISION 1.0

Viatronix, Inc.

Radiology · 15d

Cleared Nov 05, 2003

TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS...

Radiology · 15d

Cleared Nov 05, 2003

SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP...

Medtronic Perfusion Systems

Cardiovascular · 9d

Cleared Nov 04, 2003

THERATEARS CONTACT LENS COMFORT DROPS

Advanced Vision Research, Inc.

Ophthalmic · 84d

Cleared Nov 04, 2003

Cleared Nov 04, 2003

VITEK 2 GRAM NEGATIVE GATIFLOXACIN

bioMerieux, Inc.

Microbiology · 57d

Cleared Nov 04, 2003

Microbiology · 25d

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