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

70441–70464 of 174,955

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

Cleared Sep 12, 2003

MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)

Disco-O-Tech Medical Technologies, Ltd.

Orthopedic · 21d

Cleared Sep 12, 2003

3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL

Usa Instruments, Inc.

Radiology · 17d

Cleared Sep 12, 2003

RS-4I MUSCLE STIMULATOR FAMILY

Physical Medicine · 15d

Cleared Sep 12, 2003

Micro Current Technology, Inc.

Neurology · 15d

Cleared Sep 12, 2003

Horizon Medical Products, Inc.

General Hospital · 7d

Cleared Sep 11, 2003

LATEX ULTRASONIC PROBE COVER

Pleasure Latex Products Sdn. Bhd.

Radiology · 436d

Cleared Sep 11, 2003

B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM

B.T.I. Biotechnology Institute, Sl.

Cleared Sep 11, 2003

COMPOSITE RESTORATION MATERIAL

Milton Hodosh, M.D.

Cleared Sep 11, 2003

PANTOS, MODELS: PANTOS 16, AND PANTOS DG

Blue X Imaging Srl

Radiology · 92d

Cleared Sep 11, 2003

QUICKVUE INFLUENZA A+B TEST

Microbiology · 99d

Cleared Sep 11, 2003

TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6

Baylis Medical Co., Inc.

General & Plastic Surgery · 79d

Cleared Sep 11, 2003

SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM

Spinal Concepts, Inc.

Orthopedic · 76d

Cleared Sep 11, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML

Bd Diagnostic Systems

Microbiology · 59d

Cleared Sep 11, 2003

DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING

Howmedica Osteonics Corp.

Orthopedic · 37d

Cleared Sep 11, 2003

RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE...

Medtronic Vascular

Neurology · 22d

Cleared Sep 11, 2003

DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY

Planar Systems, Inc.

Radiology · 15d

Cleared Sep 11, 2003

FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM

U-Systems, Inc.

Radiology · 15d

Cleared Sep 11, 2003

MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER

Microlife Intellectual Property GmbH

General Hospital · 14d

Cleared Sep 10, 2003

PATHWAY ACCESS SHEATH CATHETER

Vertelink Corporation

Cardiovascular · 184d

Cleared Sep 10, 2003

OSTEOMED ALVEOLAR DISTRACTION SYSTEM

Cleared Sep 10, 2003

STERI-DRAPE SURGICAL DRAPES

General Hospital · 140d

Cleared Sep 10, 2003

BINDAZYME CLQ CIC EIA KIT

The Binding Site, Ltd.

Immunology · 114d

Cleared Sep 10, 2003

UNIVERSAL NEURO SYSTEM

Stryker Instruments

Cleared Sep 10, 2003

SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW...

Solarc Systems, Inc.

General & Plastic Surgery · 91d