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
77713–77736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2001
GLUSITE, MODEL GLU002
K013446 · EMA
Glustitch, Inc.
Dental · 64d
Cleared Dec 20, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
K013475 · LPH
Howmedica Osteonics Corp.
Orthopedic · 62d
Cleared Dec 20, 2001
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K013512 · LPN
Ciba Vision Corporation
Ophthalmic · 59d
Cleared Dec 20, 2001
MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)
K013901 · GEX
Cardiofocus, Inc.
General & Plastic Surgery · 24d
Cleared Dec 20, 2001
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
K013916 · BWC
Cook, Inc.
Anesthesiology · 23d
Cleared Dec 20, 2001
HAND-CARRIED ULTRASOUND SYSTEM
K014116 · IYN
Sonosite,Inc.
Radiology · 6d
Cleared Dec 19, 2001
MEDPOR COATED TEAR DRAIN
K012108 · OKS
Porex Surgical, Inc.
Ophthalmic · 166d
Cleared Dec 19, 2001
DIGICAP
K012199 · GAB
Humana USA, Inc.
General Hospital · 159d
Cleared Dec 19, 2001
ANISEIKONIA INSPECTOR
K013110 · HJT
Optical Diagnostics, Inc.
Ophthalmic · 161d
Cleared Dec 19, 2001
MICROGYN PLUS STIMULATION DEVICE
K013141 · KPI
Hollister, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 19, 2001
MULTITAK SUTURE SNAP SYSTEM
K013177 · GAM
Bonutti Research, Inc.
General & Plastic Surgery · 86d
Cleared Dec 19, 2001
SYNTHES LCP DISTAL TIBIA PLATES
K013248 · HRS
Synthes (Usa)
Orthopedic · 82d
Cleared Dec 19, 2001
BLUE LATEX EXAMINATION GLOVES, POWDER FREE
K013320 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 75d
Cleared Dec 19, 2001
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
K013346 · LYC
W.L. Gore & Associates, Inc.
Dental · 71d
Cleared Dec 19, 2001
MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
K013449 · HSB
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 63d
Cleared Dec 19, 2001
AUROFLUID PLUS
K013505 · EJT
Metalor Technologies USA
Dental · 58d
Cleared Dec 19, 2001
PRE-LOADED ULTRAFIX RC
K013553 · MBI
Linvatec Corp.
Orthopedic · 55d
Cleared Dec 19, 2001
POLARUS CAP SCREW
K013616 · HSB
Acu Med, Inc.
Orthopedic · 44d
Cleared Dec 19, 2001
PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K013798 · DZE
Institut Straumann AG
Dental · 34d
Cleared Dec 19, 2001
XIA SPINAL SYSTEM
K013823 · KWP
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Dec 19, 2001
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Dec 19, 2001
AUTO SUTURE SURGICAL STAPLES
K013860 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 28d
Cleared Dec 19, 2001
CODMAN SLIM-LOC SYSTEM
K013877 · KWQ
Codman & Shurtleff, Inc.
Orthopedic · 26d
Cleared Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989 · LZO
Smith & Nephew, Inc.
Orthopedic · 15d