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
40225–40248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2013
PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
K132203 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 66d
Cleared Sep 20, 2013
MICROPLEX COIL SYSTEM (MCS), VFC
K132317 · HCG
MicroVention, Inc.
Neurology · 57d
Cleared Sep 20, 2013
IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000...
K132391 · JJX
Siemens Helathcare Diagnostics, Inc.
Immunology · 50d
Cleared Sep 19, 2013
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
K122143 · NQN
Ventana Medical Systems, Inc.
Pathology · 427d
Cleared Sep 19, 2013
APD LUER-LOCK ADAPTER
K124024 · KDJ
Fresensius Medical Care North America
Gastroenterology & Urology · 265d
Cleared Sep 19, 2013
PHILIPS HERCEPTEST DIGITAL SCORE
K130021 · OEO
Philips Medical Systems Nederland B.V.
Pathology · 259d
Cleared Sep 19, 2013
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200...
K130053 · MVM
Bio-Rad Laboratories, Inc.
Immunology · 247d
Cleared Sep 19, 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810 · HWC
Zimmer, Inc.
Orthopedic · 178d
Cleared Sep 19, 2013
RENOVIS BIPOLAR HIP SYSTEM
K131354 · KWY
Renovis Surgical Technologies, LLC
Orthopedic · 132d
Cleared Sep 19, 2013
AUTOLAP SYSTEM
K131375 · GCJ
Mst - Medical Surgery Technologies ,...
General & Plastic Surgery · 129d
Cleared Sep 19, 2013
EQUINOX CO2 LASER
K131903 · ONG
Eclipse Aesthetics, LLC
General & Plastic Surgery · 86d
Cleared Sep 19, 2013
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K132420 · DQY
Reflow Medical
Cardiovascular · 45d
Cleared Sep 19, 2013
OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00
K132479 · MAX
Interventional Spine, Inc.
Orthopedic · 42d
Cleared Sep 19, 2013
Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM...
K132513 · MBI
ArthroCare Corporation
Orthopedic · 38d
Cleared Sep 19, 2013
PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
K132626 · LPH
Pipeline Biotechnology
Orthopedic · 28d
Cleared Sep 19, 2013
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
K132632 · MBI
Tornier, Inc.
Orthopedic · 28d
Cleared Sep 19, 2013
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT...
K132644 · MNI
Corentec Co., Ltd.
Orthopedic · 24d
Cleared Sep 18, 2013
GC-3000E DIGITAL COLPOSCOPE
K122311 · HEX
Shenzhen Goldcare Meditech Co., Ltd.
Obstetrics & Gynecology · 413d
Cleared Sep 18, 2013
ALPHA-PRO WHITE VARNISH
K124025 · LBH
Dental Technologies, Inc.
Dental · 264d
Cleared Sep 18, 2013
NAVIOS FLOW CYTOMETER SYSTEM
K130373 · OYE
Beckman Coulter, Inc.
Hematology · 216d
Cleared Sep 18, 2013
SMARTBUILDER SYSTEM (SB1)
K130840 · JEY
Osstem Implant Co., Ltd.
Dental · 175d
Cleared Sep 18, 2013
S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K131122 · OVD
Renovis Surgical Technologies, LLC
Orthopedic · 149d
Cleared Sep 18, 2013
TRANSTEK GLASS BODY FAT ANALYZER
K131394 · MNW
Guangdong Transtek Medical...
Gastroenterology & Urology · 126d
Cleared Sep 18, 2013
MEDLINE ANTI-REFLUX VALVE
K132314 · FEG
Medline Industries, Inc.
Gastroenterology & Urology · 55d