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
74953–74976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 2002
ADVIA TESTPOINT CSF CONTROL
K022968 · JPK
Bayer Diagnostics Corp.
Hematology · 18d
Cleared Sep 23, 2002
RMNIPULSE HOLMIUM LASER SYSTEM/1210
K013974 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 294d
Cleared Sep 23, 2002
STOCKERT CENTRIFUGAL PUMP CONSOLE
K020571 · DTQ
Stockert Instrumente GmbH
Cardiovascular · 214d
Cleared Sep 23, 2002
FERTILITE OV
K020808 · NGE
Pheromone Sciences Corp.
Toxicology · 195d
Cleared Sep 23, 2002
NAFD 100
K020848 · KNW
Neomatrix, LLC
Gastroenterology & Urology · 192d
Cleared Sep 23, 2002
TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B,...
K020851 · ILY
C&H International
Physical Medicine · 192d
Cleared Sep 23, 2002
TOTAL KNEE CEMENTED, SEMI-CONSTRAINED
K021740 · JWH
Dj Orthopedics, LLC
Orthopedic · 118d
Cleared Sep 23, 2002
PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119,...
K021864 · KKX
Primeline Medical Products, Inc.
General Hospital · 109d
Cleared Sep 23, 2002
TUBING, DIALYSATE (AND CONNECTOR)
K022068 · FID
Molded Products, Inc.
Gastroenterology & Urology · 90d
Cleared Sep 23, 2002
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028
K022138 · DQY
Spectranetics Corp.
Cardiovascular · 83d
Cleared Sep 23, 2002
HIP TOOL IMPLANT
K022139 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 83d
Cleared Sep 23, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR
K022220 · LYY
Shen Wei (Usa), Inc.
General Hospital · 76d
Cleared Sep 23, 2002
PLUS PIVOT LINK UNIVERSAL SYSTEM
K022271 · MNI
Spine Vision, Inc.
Orthopedic · 72d
Cleared Sep 23, 2002
3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
K022287 · EZL
3t Medical Systems, LLC
Gastroenterology & Urology · 70d
Cleared Sep 23, 2002
RESTORATION MODULAR SYSTEM
K022549 · LZO
Howmedica Osteonics Corp.
Orthopedic · 53d
Cleared Sep 23, 2002
SIGN IM NAIL
K022632 · HSB
Surgical Implant Generation Network...
Orthopedic · 47d
Cleared Sep 23, 2002
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676 · JEC
Smith & Nephew, Inc.
Orthopedic · 42d
Cleared Sep 23, 2002
CRPEX CRP CONTROLS LEVEL L, M, H
K022725 · JJX
Good Biotech Corp.
Immunology · 38d
Cleared Sep 23, 2002
TWIN FIX
K022771 · KTT
Fixano SA
Orthopedic · 33d
Cleared Sep 23, 2002
MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY
K022879 · KNW
Sanarus Medical, Inc.
Gastroenterology & Urology · 24d
Cleared Sep 20, 2002
QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
K021648 · NJF
Inova Diagnostics, Inc.
Immunology · 123d
Cleared Sep 20, 2002
SQA V, SPERM QUALITY ANALYZER
K021746 · POV
Medical Electronic Systems, LLC
Hematology · 115d
Cleared Sep 20, 2002
CVSI PERIPHERAL BALLOON CATHETER
K022061 · DQY
Cryo Vascular Systems, Inc.
Cardiovascular · 87d
Cleared Sep 20, 2002
CHASE CARDIOVASCULAR PATCH KIT
K022093 · DXZ
Chase Medical, Inc.
Cardiovascular · 85d