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
143545–143568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1986
MODEL MBA-130 MOBILE X-RAY SYSTEM
K862118 · IZL
Elscint, Inc.
Radiology · 13d
Cleared Jun 16, 1986
SCX SYSTEM
K862120 · JAA
General Electric Co.
Radiology · 13d
Cleared Jun 16, 1986
BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
K862123 · KZJ
Marion Laboratories, Inc.
Microbiology · 13d
Cleared Jun 16, 1986
TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD
K862152 · KJA
Travenol Laboratories, S.A.
Pathology · 13d
Cleared Jun 16, 1986
VENESECTION EQUIPMENT STORAGE TRAY
K862154 · FSM
Rmp Co.
General & Plastic Surgery · 11d
Cleared Jun 13, 1986
EMIT CAFFEINE ASSAY
K853872 · KLS
Syva Co.
Toxicology · 269d
Cleared Jun 13, 1986
COR DOT CMV
K853989 · GQI
Cordis Corp.
Microbiology · 259d
Cleared Jun 13, 1986
INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH
K854765 · EHP
C&C Systems, Inc.
Dental · 198d
Cleared Jun 13, 1986
BIOTEL (TM)/ DIABETES
K855239 · JIL
American Diagnostic Corp.
Chemistry · 164d
Cleared Jun 13, 1986
MODEL 486-02 ENDOCARDIAL PACING LEAD
K860547 · DTB
Intermedics, Inc.
Cardiovascular · 120d
Cleared Jun 13, 1986
MODEL 492-02 ENDOCARDIAL PACING LEAD
K860548 · DTB
Intermedics, Inc.
Cardiovascular · 120d
Cleared Jun 13, 1986
GALENICA'S DISPOSABLE ANOSCOPES
K861017 · FER
Galenica Enterprises, Inc.
Gastroenterology & Urology · 87d
Cleared Jun 13, 1986
SCEPTOR GRAM POSITIVE BREAKPOINT/ID PANEL
K861186 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 74d
Cleared Jun 13, 1986
MUREX SUDS RUBELLA
K861282 · LFX
Murex Corp.
Microbiology · 67d
Cleared Jun 13, 1986
RESPISOMNOGRAPH
K861326 · BZQ
Dickstein, Shapiro & Morin
Anesthesiology · 66d
Cleared Jun 13, 1986
SYVA SOLID PHASE COLUMNS SYSTEM II
K861392 · KZR
Syva Co.
Chemistry · 60d
Cleared Jun 13, 1986
MUREX SUDS TOXO
K861458 · LGD
Murex Corp.
Microbiology · 56d
Cleared Jun 13, 1986
DOCUMENT ENZYME LINEARITY TEST SETS
K861506 · JJT
Casco Standards
Chemistry · 51d
Cleared Jun 13, 1986
EMIT CAFFEINE CONTROL
K861511 · LAS
Syva / A Syntex Co.
Toxicology · 51d
Cleared Jun 13, 1986
ALBUMIN PROCEDURE
K861654 · CIX
Data Medical Associates, Inc.
Chemistry · 44d
Cleared Jun 13, 1986
CHOLESTEROL PROCEDURE
K861659 · CHH
Data Medical Associates, Inc.
Chemistry · 44d
Cleared Jun 13, 1986
URIC ACID PROCEDURE
K861660 · KNK
Data Medical Associates, Inc.
Chemistry · 44d
Cleared Jun 13, 1986
TOTAL PROTEIN PROCEDURE
K861663 · CEK
Data Medical Associates, Inc.
Chemistry · 44d
Cleared Jun 13, 1986
TIPSEP-TBG ASSAY
K861735 · CEE
Nuclear Diagnostics, Inc.
Chemistry · 38d