Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
167833–167856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1980
BUNN VOLUMAIRE RESPIRATORY EXERCISER
K800546 · BWF
The John Bunn Co.
Anesthesiology · 15d
Cleared Mar 25, 1980
MEDISTOR III LUNG ANALYZER
K800547 · BZC
Cybermedic, Inc.
Anesthesiology · 15d
Cleared Mar 25, 1980
TRIGLYCERIDES TEST (500NM)
K800551 · JGY
Reagents Applications, Inc.
Chemistry · 15d
Cleared Mar 25, 1980
DIFFERENTIAL REFRACTIVE INDEX DETECTOR
K800556 · KIE
Hewlett-Packard Co.
Toxicology · 13d
Cleared Mar 25, 1980
LIPID CONTROL PRODUCT # ACS LC 101
K800558 · JJY
Analytical Control Systems, Inc.
Chemistry · 13d
Cleared Mar 25, 1980
SERTROL PRODUCT # ACS ST 101
K800559 · JJY
Analytical Control Systems, Inc.
Chemistry · 13d
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