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

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175,820 results
150721–150744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1984
CANMED 101
K844100 · DRX
Medtronic Vascular
Cardiovascular · 65d
Cleared Dec 27, 1984
STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN
K844137 · DWF
Shiley, Inc.
Cardiovascular · 65d
Cleared Dec 27, 1984
STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI
K844138 · DWF
Shiley, Inc.
Cardiovascular · 65d
Cleared Dec 27, 1984
STOCKERT-SHILEY INTRACARDIAC SUCKERS
K844139 · DWF
Shiley, Inc.
Cardiovascular · 65d
Cleared Dec 27, 1984
STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH
K844140 · DWF
Shiley, Inc.
Cardiovascular · 65d
Cleared Dec 27, 1984
NELLCOR PULSE OXIMETER N-10
K844256 · DQA
Nellcor, Inc.
Anesthesiology · 55d
Cleared Dec 27, 1984
NEWPORT VENTILATOR MODEL E-100
K844350 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 48d
Cleared Dec 27, 1984
SECURIPIN
K844457 · EBL
Hughes Int'L, Inc.
Dental · 41d
Cleared Dec 27, 1984
SITE ULTRASONIC EMULSIFICATION MODULE OP
K844666 · HQC
Chiron Vision Corp.
Ophthalmic · 27d
Cleared Dec 27, 1984
THE GENERIC OXYGEN CONCENTRATOR
K844852 · CAW
Proto-Med, Inc.
Anesthesiology · 14d
Cleared Dec 24, 1984
VIBRAMETER
K843486 · LLN
Somedic AB
Neurology · 109d
Cleared Dec 24, 1984
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
K844197 · HQB
Nidek, Inc.
Ophthalmic · 55d
Cleared Dec 24, 1984
ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE
K844198 · HQB
Nidek, Inc.
Ophthalmic · 55d
Cleared Dec 24, 1984
PREMIER O2 OXYGEN CONCENTRATOR
K844223 · CAW
Everest & Jennings, Inc.
Anesthesiology · 53d
Cleared Dec 24, 1984
ME-TOO OXYGEN CONCENTRATOR
K844312 · CAW
Medequip Co.
Anesthesiology · 48d
Cleared Dec 24, 1984
MEDIPART XENON BREATHING KIT MP-01XM
K844496 · IYT
Medipart Jerry Alexander
Radiology · 34d
Cleared Dec 24, 1984
SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD
K844761 · HOY
Medical Instrument Development...
Ophthalmic · 17d
Cleared Dec 24, 1984
MIC-BIO-PLATE
K844903 · JWY
Pasco Laboratories, Inc.
Microbiology · 10d
Cleared Dec 21, 1984
ORTHOMAG MAGNETIC FORCE SYSTEM
K843550 · ECO
Medical Magnetics, Inc.
Dental · 102d
Cleared Dec 21, 1984
OPTI-LITE
K844351 · EBZ
Innovators, Inc.
Dental · 42d
Cleared Dec 20, 1984
WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
K842559 · KWL
Dow Corning Corp. Healthcare...
Orthopedic · 171d
Cleared Dec 20, 1984
ACCESS & 72X ULTRASOUND SCANHEAD UM4
K843131 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 133d
Cleared Dec 20, 1984
ULTRASOUND 72X & ANNULAR ARRAY SCAN-
K843165 · JOP
Advanced Technology Laboratories, Inc.
Cardiovascular · 129d
Cleared Dec 20, 1984
AUTORANGING DIGITAL THERMOMETER
K844273 · FLL
Micro Idea Instrument Co., Ltd.
General Hospital · 45d