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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
143449–143472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 1986
FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY
K861716 · GRZ
Whittaker Bioproducts, Inc.
Microbiology · 94d
Cleared Aug 08, 1986
GLUCOFACTS DATA PRINTER
K861779 · JQP
Miles Laboratories, Inc.
Chemistry · 92d
Cleared Aug 08, 1986
POLY-TECH ANGIOGRAPHY CATHETER
K862030 · DQO
Poly-Tech Medical Device Research &...
Cardiovascular · 72d
Cleared Aug 08, 1986
GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)
K862068 · DTM
Gelman Sciences, Inc.
Cardiovascular · 70d
Cleared Aug 08, 1986
MODIFIED OSCOR PY PACING LEADS
K862330 · DTB
Oscor Medical Corp.
Cardiovascular · 50d
Cleared Aug 08, 1986
RUBELLA IGM EIA TEST KIT
K862431 · LFX
Labsystems, Inc.
Microbiology · 43d
Cleared Aug 08, 1986
SANDARE GLYCOHEMOGLOBIN PROCEDURE
K862556 · LCP
Sandare Chemical Co., Inc.
Hematology · 36d
Cleared Aug 08, 1986
D.L. SCOPE(R) OTOSCOPE
K862661 · ERA
North American Medical Products, Inc.
Ear, Nose, Throat · 25d
Cleared Aug 08, 1986
AIRCO PRESSURE REGULATORS
K862796 · CAN
Airco, Inc.
Anesthesiology · 17d
Cleared Aug 08, 1986
AIRCO 2000 SERIES FLOWMETERS
K862797 · CAX
Airco, Inc.
Anesthesiology · 17d
Cleared Aug 07, 1986
DERMASCAN LASER SURGICAL HANDPIECE
K860083 · GEX
Medical Laser Research & Development...
General & Plastic Surgery · 210d
Cleared Aug 07, 1986
WALLANT NEUROLOGIX GENERAL PURPOSE TENS
K860847 · GZJ
Wallant Intl. Trade, Inc.
Neurology · 154d
Cleared Aug 07, 1986
ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE
K861331 · LNK
Trimedyne, Inc.
Gastroenterology & Urology · 120d
Cleared Aug 07, 1986
SCHURMAN/CARTER HIP PROSTHESIS POROUS COATED
K861450
Kirschner Medical Corp.
Orthopedic · 111d
Cleared Aug 07, 1986
THE LUNG GYM (XLATOR AND NLATOR)
K861564 · BWF
El-Fax Company, Inc.
Anesthesiology · 104d
Cleared Aug 07, 1986
BIO-CARB D16000, D16001, AND D17000
K861646 · FJH
Societe D' Analyses...
Gastroenterology & Urology · 99d
Cleared Aug 07, 1986
KIRSCHNER PROXIMAL FEMUR TOTAL HIP SYSTEM
K861826
Kirschner Medical Corp.
Orthopedic · 87d
Cleared Aug 07, 1986
FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND
K861837 · IMG
Fischer Industries, Inc.
Physical Medicine · 86d
Cleared Aug 07, 1986
OSSEODENT DRILLING SYSTEM
K862110 · KMW
Otc/America
Dental · 65d
Cleared Aug 07, 1986
MYOLAB II, MODEL ML-200
K862236 · IKN
Motion Control, Inc.
Neurology · 57d
Cleared Aug 07, 1986
ACE MOS SAW AND THE ACE MOS SPINE SAW
K862504 · JDX
Buckman Co., Inc.
Orthopedic · 37d
Cleared Aug 07, 1986
MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM
K862505 · JEY
Walter Lorenz Surgical, Inc.
Dental · 37d
Cleared Aug 07, 1986
PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS
K862534 · JEY
Walter Lorenz Surgical, Inc.
Dental · 36d
Cleared Aug 07, 1986
I81 INITIALES
K862623 · ESD
Oticon Corp.
Ear, Nose, Throat · 28d