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
154777–154800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1984
THAYER-MARTIN AGAR PLATE
K840067 · JTY
Otisville Biotech, Inc.
Microbiology · 35d
Cleared Feb 13, 1984
KV BLOOD AGAR PLATE
K840074 · JSJ
Otisville Biotech, Inc.
Microbiology · 35d
Cleared Feb 13, 1984
GN BROTH TUBE
K840076 · JSJ
Otisville Biotech, Inc.
Microbiology · 35d
Cleared Feb 10, 1984
OCUMAP 100 AUTOPERIMETER
K832555 · HPT
Shorashim
Ophthalmic · 193d
Cleared Feb 10, 1984
PAP SMEAR BRUSH
K832986 · HHT
Donald G. Zeller
Obstetrics & Gynecology · 162d
Cleared Feb 10, 1984
MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY
K833132 · EFH
Myo-Tronics Research, Inc.
Dental · 150d
Cleared Feb 10, 1984
DUAL PURPOSE CATHETER
K833375 · BSY
Jinotti Ent Inc. Medical
Anesthesiology · 135d
Cleared Feb 10, 1984
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN
K833427 · DXY
Telectronics, Inc.
Cardiovascular · 129d
Cleared Feb 10, 1984
IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN
K833428 · DXY
Telectronics, Inc.
Cardiovascular · 129d
Cleared Feb 10, 1984
BLOOD GAS EXPERSYSTEM 8700
K833430 · LLE
Medical Intelcom, Inc.
Neurology · 128d
Cleared Feb 10, 1984
ENDOSCOPIC COUPLER
K833483 · EOQ
Merrimack Laboratories
Ear, Nose, Throat · 126d
Cleared Feb 10, 1984
VZV BIO-ENZABEAD SCREEN KIT
K833637 · LFY
Bionetic Laboratory Products
Immunology · 116d
Cleared Feb 10, 1984
PULSATRON NERVE LOCATOR/STIMULATOR
K833646 · ETN
Edward Weck, Inc.
Ear, Nose, Throat · 116d
Cleared Feb 10, 1984
CARDIAC WALL MOTION DEVICE
K833728 · DSB
Intl. Medical, Inc.
Cardiovascular · 108d
Cleared Feb 10, 1984
PERCUTANEOUS RETROGRADE NEPHROSTOMY
K833762 · LJE
Vpi
Gastroenterology & Urology · 107d
Cleared Feb 10, 1984
TRANTECSILICONE QUARTZ DISP. TRANSD
K833792 · DRS
American Bentley
Cardiovascular · 102d
Cleared Feb 10, 1984
ZACT DENTAL ARCH TOOTHBRUSCH
K833815 · EFW
Jfc International, Inc.
Dental · 100d
Cleared Feb 10, 1984
TDK ECG ELECTRODE MEL-08
K833899 · DRX
Tdk Corp.
Cardiovascular · 88d
Cleared Feb 10, 1984
FIXATION PINS
K833952 · HTY
Ethicon, Inc.
Orthopedic · 86d
Cleared Feb 10, 1984
MINATURE PRESSURE TRANSDUCER
K834040 · DXO
Carbomedics, Inc.
Cardiovascular · 79d
Cleared Feb 10, 1984
PHILLY BOLTS
K834148 · GWN
Philadelphia Medical Specialties
Neurology · 86d
Cleared Feb 10, 1984
JAKOBI SURG. INSTRUMENTS #2 70/71
K834193 · FRG
Imm Enterprises , Ltd.
General Hospital · 81d
Cleared Feb 10, 1984
MATERIAL TOOTHSADE RESIN
K834247 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 65d
Cleared Feb 10, 1984
URIHESIVE SYSTEM - IMPROVED
K834337 · KNX
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 60d