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
166993–167016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1980
DISPOSABLE HAND HELD NEBULIZER
K800562 · CAF
Intec Medical, Inc.
Anesthesiology · 13d
Cleared Mar 25, 1980
BLOM-SINGER DUCKBILL VOICE PROSTHESIS
K800563 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 12d
Cleared Mar 25, 1980
IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC
K800573 · DXY
Telectronics, Inc.
Cardiovascular · 11d
Cleared Mar 25, 1980
BARNES-HOND HARD CONTACT LENS STOR. CASE
K800582 · HPX
Barnes-Hind, Inc.
Ophthalmic · 11d
Cleared Mar 25, 1980
IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD.
K800603
Telectronics, Inc.
Cardiovascular · 8d
Cleared Mar 20, 1980
PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN
K800137 · FPA
Abbott Laboratories
General Hospital · 59d
Cleared Mar 20, 1980
PHOTOVOLT PVA 4M+2 ANALYZER
K800453 · JJC
Photovolt Corp.
Chemistry · 20d
Cleared Mar 20, 1980
LIQUID-STAT LIQUID REAGENT
K800457 · CHH
Beckman Instruments, Inc.
Chemistry · 20d
Cleared Mar 20, 1980
TOBRAM E.R.A. TM
K800517 · KLQ
P-L Biochemicals, Inc.
Toxicology · 15d
Cleared Mar 20, 1980
UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA,
K800518 · HIS
Kopharm, Inc.
Obstetrics & Gynecology · 15d
Cleared Mar 20, 1980
MONEL 80&90 ULTRAVIOLET-VISIBLE SPEC.
K800523 · JJQ
Varian Assoc., Inc.
Chemistry · 14d
Cleared Mar 20, 1980
CENTRIFICHEM BUN
K800529 · CDQ
Union Carbide Corp.
Chemistry · 13d
Cleared Mar 20, 1980
CORNING TRANSPHOR
K800544 · JHX
Corning Medical & Scientific
Chemistry · 10d
Cleared Mar 20, 1980
ZEISS DISPOSABLE, STERILE SURGICAL DRAPE
K800552 · KKX
Carl Zeiss, Inc.
General Hospital · 10d
Cleared Mar 20, 1980
DAHLBERG #AZ BEHIND THE EAR HEARING AID
K800571 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 6d
Cleared Mar 19, 1980
ANTIBODY TO RUBELLA VIRUS
K792635 · GOK
Electro-Nucleonics Laboratories, Inc.
Microbiology · 91d
Cleared Mar 19, 1980
CHARCOAL YEAST EXTRACT(CYE) AGAR
K792675 · JSJ
Remel Co.
Microbiology · 83d
Cleared Mar 19, 1980
SMITH'S SYSTEMIC FUNGAL MEDIUM
K792715 · JSJ
Meridian Diagnostics, Inc.
Microbiology · 83d
Cleared Mar 19, 1980
ULTRASONIC FLOWMETER
K800087 · BXP
The Perkin-Elmer Corp.
Anesthesiology · 65d
Cleared Mar 19, 1980
HEPCON/SYSTEM RC-10
K800161 · JOX
Hemotec, Inc.
Hematology · 55d
Cleared Mar 19, 1980
VARIOUS REAGENTS FOR BLOOD CELL ANALYZER
K800180 · GIF
Laboratory Products, Inc.
Hematology · 50d
Cleared Mar 19, 1980
RIA PHASE T4
K800203 · CDX
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Mar 19, 1980
RIA PHASE TBG
K800204 · CEE
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Mar 19, 1980
RIA PHASE DIGOXIN
K800205 · DPO
Boehringer Mannheim Corp.
Chemistry · 49d