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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

175,230 results

126121–126144 of 175,230

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

Cleared May 01, 1990

I.C. MEDICAL ADJUSTABLE DIRECT COUPLER

I.C Medical, Inc.

General & Plastic Surgery · 88d

Cleared May 01, 1990

SURGILASE YAG 100 IN ORTHOPEDIC SURGERY

Surgilase, Inc.

General & Plastic Surgery · 83d

Cleared May 01, 1990

RADIATION PROTECTION GLASSES

Radiology · 60d

Cleared May 01, 1990

RADIATION PROTECTION GLOVES

Radiology · 60d

Cleared May 01, 1990

SOLAR SHADES(TM) SUNGLASSES

Blublocker Corp.

Ophthalmic · 49d

Cleared May 01, 1990

LIG/TDM A, B, C

Ciba Corning Diagnostics Corp.

Chemistry · 48d

Cleared May 01, 1990

MODIFIED ENTRAPPING FILTER

Cadema Medical Products, Inc.

General Hospital · 41d

Cleared May 01, 1990

LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC

London Diagnostics, Inc.

Chemistry · 33d

Cleared May 01, 1990

ANATOMICAL MALAR IMPLANT

Implantech Associates, Inc.

General & Plastic Surgery · 21d

Cleared May 01, 1990

3M HEAT COMFORT PORTABLE SELF-HEATING PAD

Physical Medicine · 14d

Cleared Apr 30, 1990

MODEL 3586 RESUME LEAD

Medtronic Vascular

Neurology · 476d

Cleared Apr 30, 1990

SYNTHES EXTERNAL FIXATION BONE CLIP

Orthopedic · 325d

Cleared Apr 30, 1990

Y-ADAPTER W/THOUY BORST

Cardiovascular · 227d

Cleared Apr 30, 1990

GLAUCOMA MECHANICAL TREPHINE

Trek Medical Products, Inc.

Ophthalmic · 210d

Cleared Apr 30, 1990

EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL

Ivoclar North America, Inc.

Cleared Apr 30, 1990

Konica Medical Corp.

Radiology · 151d

Cleared Apr 30, 1990

PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL

Cleared Apr 30, 1990

DISCRETION, IN THE CANAL HEARING INSTRUMENT

Gn Danavox, Inc.

Ear, Nose, Throat · 140d

Cleared Apr 30, 1990

QEKG ELECTROCARDIOGRAPH

Cardiovascular · 125d

Cleared Apr 30, 1990

NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE

Nicolet Instrument Corp.

Ear, Nose, Throat · 125d

Cleared Apr 30, 1990

BRUKER R28 WHOLE-BODY MR SCANNER

Bruker Medical Imaging, Inc.

Radiology · 117d

Cleared Apr 30, 1990

Spirometrics, Inc.

Anesthesiology · 97d

Cleared Apr 30, 1990

P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT

Johnson & Johnson International

Orthopedic · 80d

Cleared Apr 30, 1990

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.

Vitek Systems, Inc.

Microbiology · 68d