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
60025–60048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 2007
BP 101 DIGITAL BLOOD PRESSURE MONITOR
K062033 · DXN
Kingyield Hongkong Limited
Cardiovascular · 248d
Cleared Mar 23, 2007
STRYKER T6 HOODS AND TOGAS
K063005 · FYA
Stryker Instruments
General Hospital · 172d
Cleared Mar 23, 2007
CARDIOBELT ELECTRODE BELT
K063044 · DRX
Monebo Technologies, Inc.
Cardiovascular · 170d
Cleared Mar 23, 2007
EDWARDS AQUALINE STERILE TUBING SET
K063293 · FJK
Edwards Lifesciences Services GmbH
Gastroenterology & Urology · 142d
Cleared Mar 23, 2007
PET VCAR
K063324 · JAK
Ge Healthcare
Radiology · 140d
Cleared Mar 23, 2007
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
K063356 · DAP
Dade Behring, Inc.
Hematology · 136d
Cleared Mar 23, 2007
OLYMPUS TRIGLYCERIDE TEST SYSTEM
K063804 · CDT
Olympus America, Inc.
Chemistry · 91d
Cleared Mar 23, 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
K070038 · LYZ
Super Safe Plastic Products Co., Ltd.
General Hospital · 79d
Cleared Mar 23, 2007
POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
K070097 · LZA
Gx Corporation Sdn Bhd
General Hospital · 72d
Cleared Mar 23, 2007
SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10
K070142 · NGX
Bio-Medical Research Corp.
Physical Medicine · 66d
Cleared Mar 23, 2007
LINK TO ACUITY CLINICIAN NOTIFIER
K070204 · MSX
Welch Allyn Protocol, Inc.
Cardiovascular · 60d
Cleared Mar 23, 2007
ZIOSTATION
K070205 · LLZ
Ziosoft, Inc.
Radiology · 60d
Cleared Mar 23, 2007
IMPLANT SCIENCES CORP. MODEL HDR 4454
K070468 · KXK
Implant Sciences Corp.
Radiology · 35d
Cleared Mar 23, 2007
HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT
K070493 · INI
Heartway Medical Products Co., Ltd.
Physical Medicine · 31d
Cleared Mar 23, 2007
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K070526 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 28d
Cleared Mar 23, 2007
CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS
K070542 · KPS
Digirad Corp.
Radiology · 25d
Cleared Mar 23, 2007
K-Y BRAND WARMING LIQUID
K070545 · NUC
Personal Products Co.
Obstetrics & Gynecology · 25d
Cleared Mar 22, 2007
FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND...
K062014 · CAF
Flaem Nuova S.P.A.
Anesthesiology · 248d
Cleared Mar 22, 2007
MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0
K062282 · DPS
Monebo Technologies, Inc.
Cardiovascular · 227d
Cleared Mar 22, 2007
S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
K062720 · FJL
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 191d
Cleared Mar 22, 2007
ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
K063430 · KWQ
Stryker Spine
Orthopedic · 129d
Cleared Mar 22, 2007
HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL
K063568 · ILY
Suzhou Medical Appliance Factory
Physical Medicine · 114d
Cleared Mar 22, 2007
PORTI 7 PHYSIOLOGICAL AMPLIFIER
K063599 · GWL
Tms International BV
Neurology · 108d
Cleared Mar 22, 2007
POWDERED (WHITE) VINYL PATIENT EXAMINATION
K070027 · LYZ
Shijiazhuang Lianhe Shunda Plastic...
General Hospital · 78d