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

73129–73152 of 176,076

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

Cleared Mar 28, 2003

MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD

Advanced Neuromodulation Systems

Neurology · 24d

Cleared Mar 28, 2003

ECHELON MICRO CATHETER, MODEL 105-5092-150

Micro Therapeutics, Inc.

Cardiovascular · 23d

Cleared Mar 28, 2003

Aerotel Medical Systems (1998) , Ltd.

Cardiovascular · 14d

Cleared Mar 28, 2003

ER800 SERIES ECG EVENT RECORDER

Cardiovascular · 10d

Cleared Mar 28, 2003

GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM

General Electric Co.

Radiology · 8d

Cleared Mar 28, 2003

ACCOUSONIC, MODEL AS-270

Metron Medical Australia, Pty, Ltd.

Physical Medicine · 8d

Cleared Mar 27, 2003

EXEL BUTTERFLY SCALP VEIN SET

Exelint International, Co.

General Hospital · 433d

Cleared Mar 27, 2003

FLU OIA A/B TEST KIT

Thermo Biostar, Inc.

Microbiology · 155d

Cleared Mar 27, 2003

QUANTA LITE H.PYLORI IGA ELISA

Inova Diagnostics, Inc.

Microbiology · 91d

Cleared Mar 27, 2003

MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE

Genzyme Biosurgery

General & Plastic Surgery · 65d

Cleared Mar 27, 2003

ORG@NIZER, MODEL VERSION 3.0

Ebit Sanita, S.P.A.

Radiology · 51d

Cleared Mar 27, 2003

OTI SCAN WITH TRANSDUCERS

Ophthalmic Technologies, Inc.

Radiology · 16d

Cleared Mar 27, 2003

NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN

Cleared Mar 26, 2003

LOGOS JUNIOR DENTAL CHAIR AND UNIT

Castellini S.P.A.

Cleared Mar 26, 2003

Pentron Clinical Technologies

Cleared Mar 26, 2003

THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE

Cleared Mar 26, 2003

BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS

Microbiology · 93d

Cleared Mar 26, 2003

DENTAL PROTECTOR

Dental Concepts, LLC

Cleared Mar 26, 2003

CLEARFIL SILANE KIT

Kuraray Medical, Inc.

Cleared Mar 26, 2003

Micro Health Systems, Inc.

Radiology · 83d

Cleared Mar 26, 2003

MODIFICATION TO EXPORT ASPIRATION CATHETER

Medtronic Vascular

Cardiovascular · 64d

Cleared Mar 26, 2003

GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE

Pt. Wrp Buana Multicorpora

General Hospital · 58d

Cleared Mar 26, 2003

Wieland Dental + Technik GmbH & Co. KG

Cleared Mar 26, 2003

SPI ELEMENT DENTAL IMPLANT O 3.5 MM

Thommen Medical AG