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

69481–69504 of 174,955

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

Cleared Dec 15, 2003

TRIDENT RESECTION ABLATOR

General & Plastic Surgery · 14d

Cleared Dec 12, 2003

MOTILITY VISUALIZATION SYSTEM

Sierra Scientific Instruments, Inc.

Gastroenterology & Urology · 242d

Cleared Dec 12, 2003

TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03

Vascular Control Systems, Inc.

Radiology · 183d

Cleared Dec 12, 2003

VERTELINK KOBRA SPINAL FIXATION SYSTEM

Vertelink Corporation

Orthopedic · 157d

Cleared Dec 12, 2003

Bio-Tissue, Inc.

Ophthalmic · 157d

Cleared Dec 12, 2003

Shared P.E.T. Imaging, LLC

Radiology · 88d

Cleared Dec 12, 2003

Hematology · 81d

Cleared Dec 12, 2003

MISSION CONTROLS

Diamond Diagnostics, Inc.

Chemistry · 74d

Cleared Dec 12, 2003

KACEY INSULIN SYRINGE

General Hospital · 73d

Cleared Dec 12, 2003

TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA

Parallax Medical, Inc.

Neurology · 67d

Cleared Dec 12, 2003

IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER

Diagnostic Products Corp.

Chemistry · 67d

Cleared Dec 12, 2003

SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS

Anesthesiology · 59d

Cleared Dec 12, 2003

ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE

ACON Laboratories, Inc.

Toxicology · 59d

Cleared Dec 12, 2003

LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454

Toxicology · 52d

Cleared Dec 12, 2003

LARYNGEAL AUGMENTATION IMPLANT

Ear, Nose, Throat · 49d

Cleared Dec 12, 2003

LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)

Toxicology · 49d

Cleared Dec 12, 2003

FASTRAC GASTRIC ACCESS PORT KIT

C.R. Bard, Inc.

Gastroenterology & Urology · 30d

Cleared Dec 12, 2003

Terumo Medical Corp.

Cardiovascular · 29d

Cleared Dec 12, 2003

SIROSON L AND SIROSONIC L ULTRASONIC SCALERS

Sirona Dental Systems GmbH

Cleared Dec 12, 2003

VANTAGE PRO ATTENUATION CORRECTION DEVICE

Adac Laboratories

Radiology · 14d

Cleared Dec 12, 2003

BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540

Bruno Independent Living Aids, Inc.

Physical Medicine · 11d

Cleared Dec 11, 2003

VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM

Chattanooga Group

Physical Medicine · 251d

Cleared Dec 11, 2003

ALT LASER, MODEL VTR 75

Avicenna Laser Technology, Inc.

Physical Medicine · 203d

Cleared Dec 11, 2003

RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY

Radiancy (Israel) , Ltd.

General & Plastic Surgery · 146d