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
39361–39384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 2013
COMPRESSYN STAPLE
K132875 · JDR
Dallen Medical, Inc.
Orthopedic · 108d
Cleared Dec 30, 2013
G-SCAN BRIO
K133490 · LNH
Esaote, S.P.A.
Radiology · 47d
Cleared Dec 27, 2013
REUNION RSA SHOULDER SYSTEM
K130895 · PHX
Howmedica Osteonics Corp.
Orthopedic · 270d
Cleared Dec 27, 2013
NXSTAGE 1.6M2 DIALYZER
K131050 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 256d
Cleared Dec 27, 2013
LASER-STIM
K131259 · ILY
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 239d
Cleared Dec 27, 2013
CEREBRALOGIK- AEEG
K131789 · OMA
Mennen Medical , Ltd.
Neurology · 192d
Cleared Dec 27, 2013
STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER, 2 GALLON,...
K132007 · MMK
Stericycle, Inc.
General Hospital · 179d
Cleared Dec 27, 2013
EASY-LOAD LENS DELIVERY SYSTEM
K132481 · MSS
Bausch & Lomb
Ophthalmic · 141d
Cleared Dec 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
K132674 · LON
Becton, Dickinson and Company
Microbiology · 122d
Cleared Dec 27, 2013
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K133505 · IYN
Samsung Medison Co., Ltd.
Radiology · 43d
Cleared Dec 26, 2013
NEUROVISION MEDICAL MOTION SENSOR
K130570 · BZQ
Neurovision Medical Products, Inc.
Anesthesiology · 297d
Cleared Dec 26, 2013
OLEA SPHERE
K132095 · LLZ
Olea Medical
Radiology · 171d
Cleared Dec 26, 2013
KINGTECH DIGITAL THERMOMETER
K133111 · FLL
Kingtech Enterprise, Ltd.
General Hospital · 87d
Cleared Dec 26, 2013
KINGTECH FOREHEAD THERMOMETER
K133113 · FLL
Kingtech Enterprise, Ltd.
General Hospital · 87d
Cleared Dec 26, 2013
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
K133283 · GEX
Candela Corp.
General & Plastic Surgery · 62d
Cleared Dec 26, 2013
1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE
K133422 · MOS
Neocoil, LLC
Radiology · 48d
Cleared Dec 24, 2013
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS...
K123763 · CIB
Immunodiagnostic Systems , Ltd.
Chemistry · 382d
Cleared Dec 24, 2013
ARM AUTOMATIC BLOOD PRESSURE MONITOR
K130325 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 319d
Cleared Dec 24, 2013
PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS
K130519 · FTC
Philips Lighting Company
General & Plastic Surgery · 300d
Cleared Dec 24, 2013
INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM
K130572 · DZE
Implant Direct Sybron Manufacturing, LLC
Dental · 295d
Cleared CT Dec 24, 2013
SWABCAP AND SWABFLUSH
K130975 · QBP
Excelsior Medical Corp.
General & Plastic Surgery · 260d
Cleared Dec 24, 2013
SIGNIFY BIOACTIVE
K130977 · MQV
Globus Medical, Inc.
Orthopedic · 259d
Cleared Dec 24, 2013
ACUSON
K131164 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 244d
Cleared Dec 24, 2013
MOZEC - RX PTCA BALLOON DILATATION CATHETER
K131169 · LOX
Meril Life Sciences Private Limited
Cardiovascular · 244d