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
43441–43464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2012
FDR GO FLEX
K120629 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 180d
Cleared Aug 28, 2012
CATALYS PRECISION LASER SYSTEM
K121091 · OOE
Optimedica Corporation
Ophthalmic · 140d
Cleared Aug 28, 2012
ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK
K121251 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 125d
Cleared Aug 28, 2012
LARYNGEAL ELECTRODE
K121257 · ETN
Technomed Europe
Ear, Nose, Throat · 124d
Cleared Aug 28, 2012
PAX-UNI3D, PHT-7500
K121400 · OAS
VATECH Co., Ltd.
Radiology · 110d
Cleared Aug 28, 2012
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
K121482 · HRX
Theken Spine, LLC
Orthopedic · 102d
Cleared Aug 28, 2012
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
K122027 · CAZ
Arrow International, Inc.
Anesthesiology · 48d
Cleared Aug 28, 2012
TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE
K122249 · FMI
Terumo (Philippines) Corporation
General Hospital · 32d
Cleared Aug 28, 2012
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
K122296 · LZO
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Aug 28, 2012
ENLUXTRA HUMIFIBER WOUND DRESSING
K122297 · FRO
Basf Venture Capital America, Inc.
General & Plastic Surgery · 28d
Cleared Aug 28, 2012
DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION...
K122323 · CJO
Siemens Healthcare Diagnostics
Chemistry · 27d
Cleared Aug 28, 2012
VITEK 2 STRPTOCOCCUS CEFTRIAXONE
K122359 · LON
bioMerieux, Inc.
Microbiology · 25d
Cleared Aug 28, 2012
ULTHERA SYSTEM
K122528 · OHV
Ulthera, Inc.
General & Plastic Surgery · 8d
Cleared Aug 27, 2012
BAROSTAT SOFTWARE OPTION
K120997 · FFX
Crospon, Ltd.
Gastroenterology & Urology · 147d
Cleared Aug 27, 2012
TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
K121264 · HBE
Medtronic Surgical Technologies
Neurology · 123d
Cleared Aug 27, 2012
PICIS WEIGHT BASED DOSE CONVERTER
K121542 · NDC
Picis, Inc.
General Hospital · 95d
Cleared Aug 27, 2012
ACE MAGNESIUM REGENT
K122302 · JGJ
Alfa Wassermann Diagnostics...
Chemistry · 26d
Cleared Aug 24, 2012
ARJORAD STERILE WRAP
K110954 · FRG
Arjo Wiggins Medical, Inc.
General Hospital · 507d
Cleared Aug 24, 2012
RANDOX OPIATES ASSAY
K113747 · DJG
Randox Laboratories Limited
Chemistry · 248d
Cleared Aug 24, 2012
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
K120169 · CFF
Grifols USA, LLC
Immunology · 218d
Cleared Aug 24, 2012
ELEVANCE
K120239 · EIA
Midmark
Dental · 211d
Cleared Aug 24, 2012
ZIMMER TRABECULAR METAL TOTAL ANKLE
K120906 · HSN
Zimmer, Inc.
Orthopedic · 151d
Cleared Aug 24, 2012
LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE,...
K121103 · NKB
Ldr Spine USA, Inc.
Orthopedic · 135d
Cleared Aug 24, 2012
AIXPLORER
K121329 · IYN
Supersonic Imagine
Radiology · 114d