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
173305–173328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1977
VAC-RITE
K770649 · KDQ
Medical Development Co.
General Hospital · 57d
Cleared Jun 02, 1977
CARDIAC ACQUISITION SYSTEM, ICR 2001
K770705 · DQK
Instruments For Cardiac Research
Cardiovascular · 45d
Cleared Jun 02, 1977
MONITOR, PATIENT, MODEL PM-20N
K770736 · CHL
Cavitron Corp.
Chemistry · 42d
Cleared Jun 02, 1977
AEROSOL EFFUSION SYSTEM #1740
K770771 · BYH
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 35d
Cleared Jun 02, 1977
ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION
K770869 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 20d
Cleared Jun 02, 1977
SPHYGMOMANOMETER, ELECTRONIC
K770921 · DXN
Bristoline, Inc.
Cardiovascular · 13d
Cleared Jun 02, 1977
BANDAGES, SPEC. X-TRA HARD OR PLASTER
K770929 · ITG
Johnson & Johnson Professionals, Inc.
Physical Medicine · 10d
Cleared Jun 02, 1977
APPLIC SYSTEM ACTIVATOR, ESPE
K770941 · EID
Espe GmbH (Us)
Dental · 10d
Cleared Jun 02, 1977
COMPUTER ECG TELE. TRANSMISSION TERMINAL
K770949 · DXH
The Okun Co.
Cardiovascular · 8d
Cleared Jun 02, 1977
CHOLESTEROL REAGENT SET
K770998 · CHH
The Dow Chemical Co.
Chemistry
Cleared Jun 01, 1977
REAGENT SET, CHOLESTEROL, CAT NO. 4024
K770747 · CHH
American Monitor Corp.
Chemistry · 40d
Cleared Jun 01, 1977
TEST, FERROZINE IRON & IRON BINDING
K770748 · JMO
Hycel, Inc.
Chemistry · 40d
Cleared Jun 01, 1977
IMPRESSION MATERIAL, ALGINATE
K770872 · ELN
Espe GmbH (Us)
Dental · 19d
Cleared Jun 01, 1977
SIGNAL PROCESSOR/AVERAGER MODEL 7S11
K770878 · GWJ
Medical Systems Corp.
Neurology · 20d
Cleared Jun 01, 1977
ANOSCOPE, OPTIC, FIBER
K770906 · FER
Welch Allyn, Inc.
Gastroenterology & Urology · 14d
Cleared Jun 01, 1977
UROLOGICAL BIOPSY BRUSH SET
K770913 · FDX
Cook, Inc.
Gastroenterology & Urology · 13d
Cleared Jun 01, 1977
DENTAL RESTORATIVE IN CAPSULES
K770922 · EBF
Espe GmbH (Us)
Dental · 12d
Cleared Jun 01, 1977
ESPETEMP (TEMP. CEMENT)
K770923 · EMA
Espe GmbH (Us)
Dental · 12d
Cleared May 26, 1977
MEDI-PAK LEMON GLYCEOIN SWABS
K770583 · KXF
General Medical Co.
General Hospital · 59d
Cleared May 26, 1977
IV SET THAT REVERTS TO KVO RATE
K770744 · FPA
Abbott Laboratories
General Hospital · 34d
Cleared May 26, 1977
CATHETERS, OVER-THE-NEEDLE
K770751 · FOZ
Cutter Laboratories, Inc.
General Hospital · 31d
Cleared May 26, 1977
ULTIMAT L4 X L4, LIEBEL-FLARSHEIM
K770836 · KPX
Mallinckrodt Group, Inc.
Pathology · 20d
Cleared May 26, 1977
SCREEN, FINE, LANES, KODAK
K770837 · EAM
Eastman Kodak Company
Radiology · 20d
Cleared May 26, 1977
T3 UPTAKE REAGENT SET
K770845 · KHQ
The Dow Chemical Co.
Immunology · 17d