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
148993–149016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1985
TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH
K850250 · JPK
Technicon Instruments Corp.
Hematology · 69d
Cleared Apr 01, 1985
CALIBRATOR B 88133
K850405 · JIX
Hi Chem, Inc.
Chemistry · 56d
Cleared Apr 01, 1985
BED PRODUCTS
K850470 · FMQ
Abco Dealers, Inc.
General Hospital · 63d
Cleared Apr 01, 1985
SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS
K850503 · KMK
Turn Needle Intl., Inc.
General Hospital · 52d
Cleared Apr 01, 1985
CORRECT FLO INTRAVASCULAR ADMINISTRATION SET
K850506 · FPA
Biomedical Dynamics, Inc.
General Hospital · 52d
Cleared Apr 01, 1985
CHOCOLATE AGAR W/BACITRACIN, CHOCOLATE W/BACITRACI
K850555 · JSJ
Hardy Media
Microbiology · 49d
Cleared Apr 01, 1985
CEFTRIAXONE 30 MCG SENSITIVITY DISCS
K850606 · JTN
Difco Laboratories, Inc.
Microbiology · 45d
Cleared Apr 01, 1985
PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR
K850651 · DXY
Pacesetter Systems
Cardiovascular · 41d
Cleared Apr 01, 1985
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER
K850659 · JQP
Syva Co.
Toxicology · 40d
Cleared Apr 01, 1985
DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE
K850901 · CIG
Data Medical Associates, Inc.
Chemistry · 27d
Cleared Apr 01, 1985
EMIT 700 METHADONE ASSAY
K850953 · DJR
Syva Co.
Toxicology · 25d
Cleared Apr 01, 1985
DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE
K850986 · CEO
Data Medical Associates, Inc.
Chemistry · 21d
Cleared Apr 01, 1985
URI-KIT
K850998 · JSG
Culture Kits, Inc.
Microbiology · 21d
Cleared Apr 01, 1985
EYEDENTITY EYEWEAR
K851039 · HQZ
Vitech Research C/O Johnsen, Manfredi...
Ophthalmic · 18d
Cleared Apr 01, 1985
DERAPAGE EYEWEAR BY VITALONI
K851062 · HQY
Vitaloni S.P.A.
Ophthalmic · 17d
Cleared Apr 01, 1985
SPOTTEST INDIA INK
K851184 · JTO
Difco Laboratories, Inc.
Microbiology · 6d
Cleared Mar 29, 1985
URI-VAL
K843680 · JMZ
Cenogenics Corp.
Chemistry · 192d
Cleared Mar 29, 1985
RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI
K850054 · CIB
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 80d
Cleared Mar 29, 1985
LASER-GLOBIN POWDER
K850094 · GKR
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
LASER-DIL
K850095 · GIF
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
LASER-GLOBIN
K850096 · GKR
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
LASER-LYSE
K850097 · GGK
Hematology Marketing Assoc.
Hematology · 77d
Cleared Mar 29, 1985
BETASONIC III
K850116 · IYO
Teknar, Inc.
Radiology · 74d
Cleared Mar 29, 1985
ISOENZYME TEST LD-1
K850210 · CFE
Sclavo, Inc.
Chemistry · 73d