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

144649–144672 of 175,230

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

Cleared Mar 18, 1986

JMD AV FISTULA NEEDLE (MODIFICATION)

Gastroenterology & Urology · 20d

Cleared Mar 18, 1986

CAMCO STAIN PAK

Cambridge Chemical Products, Inc.

Pathology · 14d

Cleared Mar 18, 1986

CAMPYLOBACTER CVA AGAR

Gibco Laboratories Life Technologies,...

Microbiology · 11d

Cleared Mar 17, 1986

Cleared Mar 17, 1986

Cutter Laboratories, Inc.

Cleared Mar 17, 1986

DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS

Ear, Nose, Throat · 159d

Cleared Mar 17, 1986

HURWITZ AMNIOCENTESIS NEEDLE

Bd Becton Dickinson Vacutainer...

Obstetrics & Gynecology · 115d

Cleared Mar 17, 1986

ALDOSTERONE DIRECT RIA KIT

Biotecx Laboratories, Inc.

Chemistry · 101d

Cleared Mar 17, 1986

CALIBRATION REFERENCE I & II

Integrated Medical Systems Int'L., Inc.

Chemistry · 90d

Cleared Mar 17, 1986

CHEMISTRY CONTROL N & A

Integrated Medical Systems Int'L., Inc.

Chemistry · 90d

Cleared Mar 17, 1986

MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS

Medtronic Vascular

Cardiovascular · 83d

Cleared Mar 17, 1986

LEECO TESTOSTERONE DIAGNOSTIC KIT

Leeco Diagnostics, Inc.

Chemistry · 74d

Cleared Mar 17, 1986

MODEL 353C HEARING AID

Telex Communications, Inc.

Ear, Nose, Throat · 70d

Cleared Mar 17, 1986

TSH-IRMA COAT-A-COUNT KIT

Diagnostic Products Corp.

Chemistry · 70d

Cleared Mar 17, 1986

GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS)

Deringer-Ney, Inc.

Cleared Mar 17, 1986

POLYJEL N.F. (NEW FORMULA)

Cleared Mar 17, 1986

ENDOPORT 5MM SINGLE-USE TROCAR AND SLEEVE

Endotherapeutics

Obstetrics & Gynecology · 54d

Cleared Mar 17, 1986

SERIES 410 LC PUMP

The Perkin-Elmer Corp.

Toxicology · 54d

Cleared Mar 17, 1986

TOTAL BILIRUBIN REAGENT SET

Sterling Diagnostics, Inc.

Chemistry · 54d

Cleared Mar 17, 1986

NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)

Austenal Dental, Inc.

Cleared Mar 17, 1986

Degussa Dental, Inc.

Cleared Mar 17, 1986

SUCROSEP LUTEINIZING HORMONE (LH) IRMA

Boots-Celltech Diagnostics, Inc.

Chemistry · 48d

Cleared Mar 17, 1986

3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031

Johnson & Johnson Professionals, Inc.

Obstetrics & Gynecology · 48d

Cleared Mar 17, 1986

GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET

Sterling Diagnostics, Inc.

Chemistry · 46d