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

Filters: Cleared only ×
176,076 results
75457–75480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 2002
SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K022400 · IYN
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Aug 06, 2002
QUANTITATIVE BLOOD POOL SPECT (QBS)
K022428 · LLZ
Adac Laboratories
Radiology · 12d
Cleared Aug 05, 2002
MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
K001755 · FIP
Mpw Industrial Water Services, Inc.
Gastroenterology & Urology · 787d
Cleared Aug 05, 2002
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
K013704 · KLA
Mediplus , Ltd.
Gastroenterology & Urology · 270d
Cleared Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
K020672 · JZO
Roche Diagnostics Corp.
Immunology · 157d
Cleared Aug 05, 2002
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
K021357 · HPZ
Porex Surgical, Inc.
Ophthalmic · 98d
Cleared Aug 05, 2002
POLY STAT HCG DIPSTICK TEST
K021386 · JHI
Alidex, Inc.
Chemistry · 95d
Cleared Aug 05, 2002
TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS...
K021855 · LYY
Top Glove Sdn. Bhd.
General Hospital · 60d
Cleared Aug 05, 2002
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K022434 · MND
C.R. Bard, Inc.
Gastroenterology & Urology · 11d
Cleared Aug 02, 2002
POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM
K012105 · KCT
Symmetry Medical, Inc.
General Hospital · 393d
Cleared Aug 02, 2002
BABY TEETHER, MODEL 20104
K014023 · KKO
Angelina Trading, Inc.
Dental · 239d
Cleared Aug 02, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON...
K020120 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 200d
Cleared Aug 02, 2002
CRC-15BT
K020150 · KPT
Capintec, Inc.
Radiology · 198d
Cleared Aug 02, 2002
BONESOURCE HAC
K021440 · GXP
Stryker Instruments
General & Plastic Surgery · 88d
Cleared Aug 02, 2002
RAPIDO GUIDING CATHETER, 6F MODEL# 6776
K021455 · DQY
Guidant Corp.
Cardiovascular · 88d
Cleared Aug 02, 2002
C.T.M. POWER CHAIR, MODEL HS-2800
K021617 · ITI
C.T.M. Homecare Product, Inc.
Physical Medicine · 78d
Cleared Aug 02, 2002
DISETRONIC D-TRON INSULIN INFUSION PUMP
K021725 · LZG
Disetronic Medical Systems AG
General Hospital · 70d
Cleared Aug 02, 2002
MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR
K022101 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 35d
Cleared Aug 02, 2002
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K022246 · FMF
Depuyacromed
General Hospital · 21d
Cleared Aug 02, 2002
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, &...
K022317 · LZG
Sooil Development Co., Ltd.
General Hospital · 16d
Cleared Aug 02, 2002
RELYX RMGIP
K022476 · EMA
3M Company
Dental · 4d
Cleared Aug 01, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K012687 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 352d
Cleared Aug 01, 2002
MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
K012693 · CBK
Acutronic Medical Systems AG
Anesthesiology · 352d
Cleared Aug 01, 2002
PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
K013093 · CAH
Pall Medical
General Hospital · 318d