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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
42025–42048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 2013
GRIDLOCK PLATING SYSTEM
K123525 · HRS
Trilliant Surgical, Ltd.
Orthopedic · 92d
Cleared Feb 15, 2013
2008 HEMODIALYSIS SORBENT SYSTEM
K123835 · FKT
Renal Solutions, Inc.
Gastroenterology & Urology · 64d
Cleared Feb 15, 2013
PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
K130200 · CHH
Abaxis, Inc.
Chemistry · 18d
Cleared Feb 14, 2013
A200 KNEE SYSTEM
K120038 · OIY
Renovis Surgical Technologies, LLC
Orthopedic · 406d
Cleared Feb 14, 2013
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING...
K120181 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 391d
Cleared Feb 14, 2013
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES
K120673 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 346d
Cleared Feb 14, 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES
K120675 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 346d
Cleared Feb 14, 2013
MALE LATEX CONDOM
K121241 · HIS
Nulatex Sdn. Bhd.
Obstetrics & Gynecology · 295d
Cleared Feb 14, 2013
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT...
K121433 · LFR
Hmd Biomedical, Inc.
Chemistry · 276d
Cleared Feb 14, 2013
SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV
K121919 · KKX
Exact Medical Manufacturing, Inc.
General Hospital · 227d
Cleared Feb 14, 2013
LIFESTYLES NATURAL PERSONAL LUBRICANT
K122054 · NUC
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 216d
Cleared Feb 14, 2013
ECG CHECK
K122184 · DXH
Cardiac Designs, LLC
Cardiovascular · 206d
Cleared Feb 14, 2013
VASHE WOUND THERAPY SOLUTION
K123072 · FRO
Puricore, Inc.
General & Plastic Surgery · 136d
Cleared Feb 14, 2013
TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS...
K123166 · JWH
Howmedica Osteonics Corp.
Orthopedic · 128d
Cleared Feb 14, 2013
ISO-GARD CLEARAIR MASK
K123176 · CBN
Teleflexmedical, Inc.
Anesthesiology · 127d
Cleared Feb 14, 2013
A5 ANESTHESIA DELIVERY SYSTEM
K123211 · BSZ
Datascope Corp., Patient Monitoring...
Anesthesiology · 125d
Cleared Feb 14, 2013
EQUAFLOW MULTIVALVE INFUSION CATHETER
K123235 · DYB
Cook Incorporated
Cardiovascular · 121d
Cleared Feb 14, 2013
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
K123240 · MBI
ArthroCare Corporation
Orthopedic · 121d
Cleared Feb 14, 2013
ILLICO MIS POSTERIOR FIXATION SYSTEM
K123623 · NKB
Alphatec Spine, Inc.
Orthopedic · 83d
Cleared Feb 14, 2013
CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE
K123647 · JOW
Devon Medical, Inc.
Cardiovascular · 79d
Cleared Feb 14, 2013
VITRO MOLAR
K123826 · EMA
Dfl Industria E Comercio SA
Dental · 64d
Cleared Feb 14, 2013
CONNECT FOR DA VINCI SURGICAL SYSTEM(S)
K123840 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 63d
Cleared Feb 14, 2013
GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
K123851 · JJX
Bionostics, Inc.
Chemistry · 62d
Cleared Feb 14, 2013
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM
K123918 · HRS
Zimmer, Inc.
Orthopedic · 57d