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
173185–173208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1977
DYLADE, MODEL DS
K771065 · FKP
Milton Roy Co. Analytical
Gastroenterology & Urology · 11d
Cleared Jun 24, 1977
MULTISONIC (SUPER) CODE TSM
K771069 · ESD
Qualitone
Ear, Nose, Throat · 11d
Cleared Jun 24, 1977
ORTHODONTIC BRACKET ADHESIVE
K771076 · DYH
Lee Pharmaceuticals
Dental · 9d
Cleared Jun 24, 1977
ULTRAVIOLET RAD-EMITTING LAMP
K771077 · EBZ
Lee Pharmaceuticals
Dental · 9d
Cleared Jun 24, 1977
LITECAST CERAMIC
K771081 · EJH
Williams Gold Refining Co., Inc.
Dental · 9d
Cleared Jun 24, 1977
DELTASCAN 2000 SERIES
K771082 · JAK
Ohio Nuclear, Inc.
Radiology · 9d
Cleared Jun 24, 1977
J HOOK HEADGEAR
K771095 · DZB
Northwest Orthodontics, Inc.
Dental · 4d
Cleared Jun 24, 1977
URETHRAL TRAY W/CATHETER, 7750
K771103 · FCM
Concord Laboratories, Inc.
Gastroenterology & Urology · 4d
Cleared Jun 24, 1977
URETHRAL TRAY W/OUT CAHTETER, 7650
K771104 · FCM
Concord Laboratories, Inc.
Gastroenterology & Urology · 4d
Cleared Jun 23, 1977
MERCURY/HYDRIDE SYSTEM MHS-1
K770637 · DOP
The Perkin-Elmer Corp.
Toxicology · 80d
Cleared Jun 23, 1977
PANEL, GNF, MICRO-ID
K770745 · JSW
Micro-Media Systems, Inc.
Microbiology · 62d
Cleared Jun 23, 1977
PANEL, IDENTIFICATION, STREP, MICRO-ID
K770746 · JSE
Micro-Media Systems, Inc.
Microbiology · 62d
Cleared Jun 23, 1977
CENTRIA CORTISOL RIA
K771117 · CGR
Clinical Diagnostics, Inc.
Immunology · 2d
Cleared Jun 22, 1977
REAGENT SYSTEM, PROGESTERONE, ARIA
K770732 · JLS
Bd Becton Dickinson Vacutainer...
Immunology · 63d
Cleared Jun 22, 1977
REAGENT SET, T-4, CPB
K770737 · CDX
G.D. Searle and Co.
Immunology · 62d
Cleared Jun 22, 1977
REAGENT, T-3 UPTAKE
K770738 · CDP
G.D. Searle and Co.
Immunology · 62d
Cleared Jun 22, 1977
SERUM SET, THYROID CONTROL
K770739 · CDP
G.D. Searle and Co.
Immunology · 62d
Cleared Jun 22, 1977
RADIOASSAY TUBES & RADIOASSAY TUBE CAPS
K770740 · JJJ
G.D. Searle and Co.
Immunology · 62d
Cleared Jun 22, 1977
SKIN SCRUB PREP SET
K770796 · KKX
Lukens Corp.
General Hospital · 51d
Cleared Jun 22, 1977
TRAY, IRRIGATION, STERILE, BASIC
K770799 · KKX
Lukens Corp.
General Hospital · 51d
Cleared Jun 22, 1977
PHENOBARBITAL ANALYTICAL TEST PACKS
K770919 · DLZ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 34d
Cleared Jun 22, 1977
TOTAL THYROXINE (RIA) REAGENT SET
K770940 · CDX
The Dow Chemical Co.
Immunology · 29d
Cleared Jun 22, 1977
HUMAN REFERENCE SERUM
K770965
Kallestad Laboratories, Inc.
Immunology · 26d
Cleared Jun 22, 1977
MULTISONIC (DELUXE) CODE TDM
K771029 · ESD
Qualitone
Ear, Nose, Throat · 13d