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
55321–55344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2008
POLYBONE GRANULE & BLOCK
K082338 · MQV
Kyung Won Medical Co., Ltd.
Orthopedic · 63d
Cleared Oct 16, 2008
OSDX HIP BMD SYSTEM
K082402 · KGI
Imaging Therapeutics, Inc.
Radiology · 57d
Cleared Oct 16, 2008
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM...
K082615 · MQV
Osteotech, Inc.
Orthopedic · 37d
Cleared Oct 16, 2008
MODIFICATION TO: CAPSTONE SPINAL SYSTEM
K082732 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Oct 16, 2008
STRAIGHT FIRE HOLMIUM LASER FIBER
K082928 · GEX
Boston Scientific Corp
General & Plastic Surgery · 15d
Cleared Oct 16, 2008
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K082944 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 14d
Cleared Oct 15, 2008
HELONTIX VENT
K072926 · CBK
Linde Gas Therapeutics
Anesthesiology · 366d
Cleared Oct 15, 2008
VRIICU SYSTEM
K073582 · OCR
Deep Breeze , Ltd.
Anesthesiology · 300d
Cleared Oct 15, 2008
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS
K080632 · MVN
Clearlab SG Pte, Ltd.
Ophthalmic · 224d
Cleared Oct 15, 2008
NXSTAGE PUREFLOW SL
K080919 · FKR
Nxstage Medical, Inc.
Gastroenterology & Urology · 197d
Cleared Oct 15, 2008
FLOWPICC CONSOLE
K081626 · OBJ
Vasonova, Inc.
Cardiovascular · 127d
Cleared Oct 15, 2008
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT
K081674 · MST
The Binding Site, Ltd.
Immunology · 120d
Cleared Oct 15, 2008
APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
K081710 · OTP
American Medical Systems
Obstetrics & Gynecology · 120d
Cleared Oct 15, 2008
PRELUDE SHORT SHEATH INTRODUCER
K082063 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 86d
Cleared Oct 15, 2008
MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III
K082081 · HSX
Mako Surgical Corp.
Orthopedic · 84d
Cleared Oct 15, 2008
DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE...
K082092 · BTM
Galemed Corp.
Anesthesiology · 83d
Cleared Oct 15, 2008
DENSEO FAIRY
K082158 · EIH
Xpdent Corp
Dental · 76d
Cleared Oct 15, 2008
EVIS MD PLANTIUM BLUE
K082232 · GEX
Ageless Beauty Corporation
General & Plastic Surgery · 69d
Cleared Oct 15, 2008
XR-EXPRESS
K082336 · LLZ
New Mexico Software, Inc.
Radiology · 62d
Cleared Oct 15, 2008
ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS
K082398 · LZO
Encore Medical, L.P.
Orthopedic · 56d
Cleared Oct 15, 2008
CURATIVE980 DIODE LASER
K082445 · GEX
Oroscience, Inc.
General & Plastic Surgery · 51d
Cleared Oct 15, 2008
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
K082446 · KWA
Biomet, Inc.
Orthopedic · 51d
Cleared Oct 15, 2008
ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL,...
K082666 · GEI
Arthrocare Corp.
General & Plastic Surgery · 33d
Cleared Oct 15, 2008
VACORA VACUUM ASSISTED BIOPSY SYSTEM
K082681 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 30d