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
77953–77976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 2001
KP + LFM
K013489 · BZH
Pds Healthcare Products, Inc.
Anesthesiology · 38d
Cleared Nov 29, 2001
MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE
K013845 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 9d
Cleared Nov 28, 2001
DISPOSABLE STORAGE CAP
K010366 · FJI
Molded Products, Inc.
Gastroenterology & Urology · 294d
Cleared Nov 28, 2001
MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
K010607 · LJH
Benlan, Inc.
Gastroenterology & Urology · 272d
Cleared Nov 28, 2001
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 162d
Cleared Nov 28, 2001
BIOPLATE RESORBABLE BONE SCREW
K012908 · DZL
Bioplate, Inc.
Dental · 90d
Cleared Nov 28, 2001
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
K012917 · HFW
Dynarex Corp.
Obstetrics & Gynecology · 90d
Cleared Nov 28, 2001
MOLDED CRANIAL HELMET
K012920 · MVA
Fairview Orthopedic Laboratory
Neurology · 90d
Cleared Nov 28, 2001
TCM ENDO III
K013185 · EFA
NOUVAG AG
Dental · 65d
Cleared Nov 28, 2001
PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL...
K013199 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 64d
Cleared Nov 28, 2001
TOTAL O2
K013472 · CAW
Chad Therapeutics, Inc.
Anesthesiology · 41d
Cleared Nov 28, 2001
CORDIS AVIATOR PERIPHERAL DILATATION CATHETER
K013581 · DQY
Cordis, A Johnson & Johnson Co.
Cardiovascular · 30d
Cleared Nov 28, 2001
MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM
K013682 · DZE
Basic Dental Implant Systems, Inc.
Dental · 21d
Cleared Nov 28, 2001
SILMED NASAL SEPTAL BUTTON
K013696 · LFB
Silmed, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 27, 2001
PERIOLASE ND:YAG DENTAL LASER SYSTEM
K010771 · GEX
Millennium Dental Technologies, Inc.
General & Plastic Surgery · 258d
Cleared Nov 27, 2001
ORALLITE COMPREHENSIVE EXAM TRAY
K012070 · MPU
Trylon Corp.
Obstetrics & Gynecology · 148d
Cleared Nov 27, 2001
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K012516 · KWP
Ebi, L.P.
Orthopedic · 113d
Cleared Nov 27, 2001
FRONTIER ANTERIOR SCOLIOSIS SYSTEM
K012916 · KWQ
Depuy Acromed, Inc.
Orthopedic · 89d
Cleared Nov 27, 2001
APEX MODULAR ALUMINA FEMORAL HEAD
K012918 · LZO
Apex Surgical, LLC
Orthopedic · 89d
Cleared Nov 27, 2001
WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20...
K013145 · CIT
Wiener Laboratories Saic
Chemistry · 68d
Cleared Nov 27, 2001
RUSCH POLYFLEX STENT KIT
K013266 · NYT
Rusch Intl.
General & Plastic Surgery · 57d
Cleared Nov 27, 2001
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71
K013731 · EOQ
Gimmi GmbH
Ear, Nose, Throat · 18d
Cleared Nov 27, 2001
CARDIOVASCULAR ARRAY
K013810 · MOS
W.L. Gore & Associates, Inc.
Radiology · 12d
Cleared Nov 26, 2001
COMPRESSIBLE LIMB SLEEVE
K011192 · JOW
Alliance Medical Corp.
Cardiovascular · 221d