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
51649–51672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2009
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
K093458 · JFY
Beckman Coulter, Inc.
Chemistry · 28d
Cleared CT Dec 04, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963
K093528 · DXN
Andon Health Co, Ltd.
Cardiovascular · 18d
Cleared Dec 04, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
K093570 · LYZ
Jiangsu Jaysun Glove Co., Ltd.
General Hospital · 16d
Cleared Dec 04, 2009
OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM
K093600 · KPI
Accelerated Care Plus
Gastroenterology & Urology · 14d
Cleared Dec 03, 2009
ZOLL E SERIES WITH SPCO/SPMET OPTION
K092598 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 101d
Cleared Dec 03, 2009
XIA 4.5 SPINAL SYSTEM
K092605 · NKB
Stryker Spine
Orthopedic · 101d
Cleared Dec 03, 2009
SIROLASER ADVANCE
K092660 · GEX
Sirona Dental Systems GmbH
General & Plastic Surgery · 97d
Cleared Dec 03, 2009
H100B PULSE OXIMETER
K092727 · DQA
Edan Instruments, Inc.
Anesthesiology · 90d
Cleared Dec 03, 2009
MAS AND MINI-TROL PTH CONTROL
K092749 · JJX
Microgenics Corporation
Immunology · 86d
Cleared Dec 03, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K092820 · LYZ
Shijiazhuang Fuhao Plastic Products...
General Hospital · 80d
Cleared Dec 03, 2009
INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL
K092840 · HCZ
Instrumed International, Inc.
Obstetrics & Gynecology · 79d
Cleared Dec 03, 2009
SILS PORT MODEL SILSPT15
K093372 · GCJ
Covidien Lp, Formerly Registered AS...
General & Plastic Surgery · 35d
Cleared Dec 03, 2009
VITA VMK MASTER
K093446 · EIH
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
Dental · 28d
Cleared Dec 03, 2009
STIMPOD MODEL NMS-400 NERVE STIMULATOR
K093591 · BXN
Xavant Technology (Pty), Ltd.
Anesthesiology · 14d
Cleared Dec 03, 2009
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
K093639 · HJO
Huvitz Co., Ltd.
Ophthalmic · 9d
Cleared Dec 02, 2009
MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR
K090526 · MUH
E-Woo Technology
Radiology · 279d
Cleared Dec 02, 2009
TSO3 OZONE STERILIZER, MODEL 125L
K090636 · FLF
Tso3, Inc.
General Hospital · 267d
Cleared Dec 02, 2009
RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI...
K091111 · CAF
Instrumentation Industries, Inc.
Anesthesiology · 229d
Cleared Dec 02, 2009
LIFT CHAIR, MODEL T3
K091578 · INO
Pride Mobility Products Corp.
Physical Medicine · 183d
Cleared Dec 02, 2009
IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4...
K091934 · JAK
Veran Medical Technologies, Inc.
Radiology · 155d
Cleared Dec 02, 2009
X-SMART EASY
K092614 · EKX
Dentsply Interntional
Dental · 98d
Cleared Dec 02, 2009
INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA...
K092639 · LLZ
GE Medical Systems SCS
Radiology · 97d
Cleared Dec 02, 2009
PENTAX ED-3490TK, VIDEO DUODENOSCOPE
K092710 · FDT
Pentax Medical Company
Gastroenterology & Urology · 90d
Cleared Dec 02, 2009
DYNA LOCKING IM NAIL
K092771 · HSB
U&I Corp.
Orthopedic · 84d