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

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176,076 results
66769–66792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2005
CD HORIZON SPINAL SYSTEM
K050079 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Feb 10, 2005
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
K050220 · EOQ
Olympus Medical Systems Corporation
Ear, Nose, Throat · 10d
Cleared Feb 09, 2005
DIAMOND MEDISTIM
K041390 · IPF
Diamond Systems USA, Inc.
Physical Medicine · 260d
Cleared Feb 09, 2005
SCORPIO NRG KNEE SYSTEM
K042343 · JWH
Howmedica Osteonics Corp.
Orthopedic · 163d
Cleared Feb 09, 2005
SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY
K043122 · LLZ
Siemens AG
Radiology · 89d
Cleared Feb 09, 2005
ALCOHAWK PRECISION
K043188 · DJZ
Q3 Innovations, LLC
Chemistry · 84d
Cleared Feb 09, 2005
SONALIS, MODEL 2000
K043189 · IYO
3g Ultrasound, Inc.
Radiology · 84d
Cleared Feb 09, 2005
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
K043251 · GEX
Candela Corp.
General & Plastic Surgery · 78d
Cleared Feb 09, 2005
BONE SOURCE HAC RAPID SETTING CEMENT
K043334 · GXP
Stryker Instruments
General & Plastic Surgery · 68d
Cleared Feb 09, 2005
HL 188 & HL 189 BODY FAT METER
K043414 · MNW
Health & Life Co., Ltd.
Gastroenterology & Urology · 58d
Cleared Feb 09, 2005
HEMOSIL FACTOR XII DEFICIENT PLASMA
K043459 · GJT
Instrumentation Laboratory CO
Hematology · 56d
Cleared Feb 09, 2005
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
K043505 · KWT
Biomet, Inc.
Orthopedic · 51d
Cleared Feb 09, 2005
CATHETER INTRODUCER
K043525 · DYB
Galt Medical Corp.
Cardiovascular · 50d
Cleared Feb 09, 2005
ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D
K043612 · EHD
Instrumentarium Corp. Imaging Division
Radiology · 41d
Cleared Feb 09, 2005
OXYTEC, MODEL 900
K043615 · CAW
Oxytec Medical Corporation
Anesthesiology · 41d
Cleared Feb 09, 2005
RETRACTOFOAM
K050013 · ELW
Coltene/Whaledent AG
Dental · 37d
Cleared Feb 09, 2005
PROSTATE-63 CANCER DIAGNOSTIC TEST
K050063 · NTR
Asymmetrx
Pathology · 29d
Cleared Feb 09, 2005
LNOPV AD-L AND PD-L OXIMETRY SENSORS
K050068 · DQA
Masimo Corporation
Anesthesiology · 28d
Cleared Feb 09, 2005
MULTIDIAGNOST ELEVA
K050151 · KPR
Philips Medical Systems North...
Radiology · 16d
Cleared Feb 09, 2005
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
K050202 · CGR
Beckman Coulter, Inc.
Chemistry · 12d
Cleared Feb 08, 2005
CALM PATTERNS, VERSION 01.00.00
K040788 · HGM
Lms Medical Systems , Ltd.
Obstetrics & Gynecology · 316d
Cleared Feb 08, 2005
ADVIA IMS VALPROIC ACID METHOD
K042807 · LEG
Bayer Healthcare, LLC
Chemistry · 119d
Cleared Feb 08, 2005
ADVIA IMS CARBAMAZEPINE METHOD
K042808 · KLT
Bayer Healthcare, LLC
Chemistry · 119d
Cleared Feb 08, 2005
STEREOTAXIS ENDOVASCULAR GUIDE WIRE
K042854 · DQX
Stereotaxis, Inc.
Cardiovascular · 116d