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
37153–37176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 2014
TABLO CONSOLE
K140866 · KDI
Home Dialysis Plus
Gastroenterology & Urology · 160d
Cleared Sep 10, 2014
NOVAGUARD S A SAFETY SYSTEM
K141464 · MEG
West Pharmaceutical Services
General Hospital · 99d
Cleared Sep 10, 2014
GLOBE-TROTTER GT5400
K141565 · FPL
Draeger Medical Systems, Inc.
General Hospital · 90d
Cleared Sep 10, 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS
K141835 · MNI
Spineart
Orthopedic · 65d
Cleared Sep 10, 2014
TRIDENT FUSION IMPLANT
K141937 · HWC
Vilex IN Tennessee, Inc.
Orthopedic · 55d
Cleared Sep 10, 2014
VIA SPINOUS PROCESS FIXATION SYSTEM
K142213 · PEK
Spineology, Inc.
Orthopedic · 29d
Cleared Sep 10, 2014
Apollo Suture Anchor System and Titan Screws
K142230 · MBI
Valeris Medical
Orthopedic · 28d
Cleared Sep 10, 2014
Direxion Torqueable Microcatheter
K142259 · KRA
Boston Scientific Corp
Cardiovascular · 27d
Cleared Sep 10, 2014
EyeSuite Imaging
K142423 · NFJ
Haag-Streit AG
Ophthalmic · 13d
Cleared Sep 09, 2014
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K131340 · LYZ
Made Plastic Co., Ltd.
General Hospital · 488d
Cleared Sep 09, 2014
SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE
K133963 · MPN
Adhezion Biomedical, LLC
General & Plastic Surgery · 259d
Cleared Sep 09, 2014
FUJIFILM ENDOSCOPIC CO2 REGULATOR
K133976 · FCX
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 257d
Cleared Sep 09, 2014
ZEISS CATARACT SUITE MARKERLESS
K141068 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 138d
Cleared Sep 09, 2014
SPACELABS HEALTHCARE TELEMETRY RECEIVER
K141156 · MHX
Spacelabs Healthcare
Cardiovascular · 127d
Cleared Sep 09, 2014
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL...
K141244 · FRC
North American Science Assoc., Inc.
General Hospital · 118d
Cleared Sep 09, 2014
ECARE COORDINATOR (ECC)
K141706 · DRG
Visicu, Inc.
Cardiovascular · 77d
Cleared Sep 09, 2014
FRIMAP ADAPTER CONNECTOR (MAC)
K142182 · MTD
Topera, Inc.
Cardiovascular · 32d
Cleared Sep 09, 2014
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
K142395 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared Sep 08, 2014
IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM
K133584 · CGA
Eoshealth, Inc.
Chemistry · 291d
Cleared Sep 08, 2014
ARENA-C
K141337 · ODP
Spinefrontier, Inc.
Orthopedic · 110d
Cleared Sep 08, 2014
XIDF-AWS801, ANGIO WORKSTATION, V5.31
K141541 · JAA
Toshibamedical Systems Corporation
Radiology · 90d
Cleared Sep 08, 2014
PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70...
K141551 · PGW
Stryker Corporate
Ear, Nose, Throat · 89d
Cleared Sep 08, 2014
RANGE/MESA/DENALI SPINAL SYSTEM
K141873 · NKB
K2m, Inc.
Orthopedic · 59d
Cleared Sep 08, 2014
HD BLOOD PRESSURE MONITOR
K141924 · DXN
Biocare Asia Corporation , Ltd.
Cardiovascular · 54d