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

70609–70632 of 176,076

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

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

Cleared Dec 11, 2003

Orthopedic · 141d

Cleared Dec 11, 2003

H/S CATHETER SET

Catheter Research, Inc.

Obstetrics & Gynecology · 91d

Cleared Dec 11, 2003

SPECTRA PULSED DIODE LASER, MODEL DR-1

Spectragenics, Inc.

General & Plastic Surgery · 91d

Cleared Dec 11, 2003

ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER,...

Transonic Systems, Inc.

Cardiovascular · 49d

Cleared Dec 11, 2003

INFINITY GAMMAXL

Draeger Medical Systems, Inc.

Cardiovascular · 27d

Cleared Dec 11, 2003

SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800

Cobe Cardiovascular, Inc.

Cardiovascular · 21d

Cleared Dec 11, 2003

M2376A PHILIPS DEVICE LINK SYSTEM

Philips Medical Systems

Cardiovascular · 17d