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

Filters: Cleared only ×
176,076 results
73441–73464 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K030431 · MHX
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Feb 26, 2003
MODIFICATION TO THE MAESTRO SYSTEM
K030463 · DZE
BioHorizons Implant Systems, Inc.
Dental · 14d
Cleared Feb 26, 2003
SENORX ES-300
K030473 · GEI
Senorx, Inc.
General & Plastic Surgery · 14d
Cleared Feb 25, 2003
JAX
K010555 · MQV
Smith & Nephew, Inc.
Orthopedic · 729d
Cleared Feb 25, 2003
U2 ACETABULAR CUP
K022520 · LPH
United Orthopedic Corp.
Orthopedic · 210d
Cleared Feb 25, 2003
NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES
K023949 · HAW
Image-Guided Neurologics, Inc.
Neurology · 90d
Cleared Feb 25, 2003
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE...
K024100 · LIH
Theratech, Inc.
Neurology · 75d
Cleared Feb 25, 2003
MICROSURGICAL BIPOLAR HANDPIECE
K024304 · GEI
Neomedix Corp.
General & Plastic Surgery · 63d
Cleared Feb 25, 2003
FIRST RESPONSE PREGNANCY TEST
K030258 · LCX
Armkel, LLC
Chemistry · 32d
Cleared Feb 25, 2003
MODIFICATION TO TSRH SPINAL SYSTEM
K030285 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Feb 25, 2003
TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX
K030299 · FLL
Oriental System Technology, Inc.
General Hospital · 27d
Cleared Feb 25, 2003
UNICONDYLAR FEMORAL COMPONENT
K030301 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Feb 24, 2003
MEDCOMP SC4
K022678 · MSD
Medcomp
Gastroenterology & Urology · 196d
Cleared Feb 24, 2003
OXYBOX SYSTEM
K023456 · KPJ
Oxyfast Corporation
General & Plastic Surgery · 132d
Cleared Feb 24, 2003
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A,...
K023931 · HGM
Philips Medical Systems, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 24, 2003
CLOCKMINI, MODEL DF301
K023942 · MNW
Yamato Corp.
Gastroenterology & Urology · 90d
Cleared Feb 24, 2003
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
K024210 · DGC
Beckman Coulter, Inc.
Immunology · 66d
Cleared Feb 24, 2003
WAKO L-TYPE GLUCOSE 2
K024281 · CFR
Wako Chemicals USA, Inc.
Chemistry · 63d
Cleared Feb 24, 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
K030042 · MOS
Usa Instruments, Inc.
Radiology · 49d
Cleared Feb 24, 2003
LIQUICHEK D-DIMER CONTROL, MODEL 356, 357
K030182 · GGN
Bio-Rad
Hematology · 38d
Cleared Feb 24, 2003
BIORAPID MONONUCLEOSIS
K030215 · KTN
Instrumentation Laboratory CO
Immunology · 34d
Cleared Feb 21, 2003
PMH 1000 HEATED HUMIDIFIER
K013856 · BTT
Pegasus Research Corp.
Anesthesiology · 472d
Cleared Feb 21, 2003
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
K021945 · IZH
Planmed OY
Radiology · 253d
Cleared Feb 21, 2003
MACROPORE SURGICAL BARRIER FILM
K023643 · MTZ
Macropore Biosurgery, Inc.
Ophthalmic · 114d