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
52753–52776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2009
NUVASIVE SPHERX II SYSTEM
K091502 · NKB
Nuvasive, Inc.
Orthopedic · 62d
Cleared Jul 22, 2009
ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER
K091832 · OCW
Endogastric Solutions, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 21, 2009
EZ HSG CATHETER.FOAMSEAL CATHETER
K083594 · LKF
Obg Products
Obstetrics & Gynecology · 228d
Cleared Jul 21, 2009
PARI PEP S
K090829 · BWF
Pari Respiratory Equipment, Inc.
Anesthesiology · 117d
Cleared Jul 21, 2009
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
K090830 · FBK
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 117d
Cleared Jul 21, 2009
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
K091075 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 98d
Cleared Jul 21, 2009
GOLD ANCHOR
K091645 · IYE
Naslund Medical AB
Radiology · 47d
Cleared Jul 21, 2009
BOLUS COMPENSATOR
K091911 · IXI
.Decimal, Inc.
Radiology · 26d
Cleared Jul 21, 2009
QXLINK
K092081 · LLZ
Vieworks Co., Ltd.
Radiology · 12d
Cleared Jul 20, 2009
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES
K082982 · ONZ
Breathe Technologies, Inc.
Anesthesiology · 287d
Cleared Jul 20, 2009
FLORASEAL, MODEL FS350D
K083354 · NZP
Adhezion Biomedical
General Hospital · 249d
Cleared Jul 20, 2009
MD300K1 PULSE OXIMETER
K090599 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 137d
Cleared Jul 20, 2009
STIMULUS/DISSECTION INSTRUMENTS
K090838 · ETN
Axon Systems, Inc.
Ear, Nose, Throat · 115d
Cleared Jul 20, 2009
LEKSELL GAMMAPLAN
K090972 · MUJ
Elekta Instrument AB
Radiology · 105d
Cleared Jul 20, 2009
VINYL POWDERED EXAMINATION GLOVE
K091384 · LYZ
Shun Tong Co., Ltd.
General Hospital · 70d
Cleared Jul 20, 2009
PERFSCAPE
K091444 · LNH
Olea Medical
Radiology · 66d
Cleared Jul 20, 2009
DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)
K091760 · MSD
Dermaport, Inc.
Gastroenterology & Urology · 34d
Cleared Jul 20, 2009
PROGENY VANTAGE PANORAMIC X-RAY SYSTEM
K091866 · MUH
Midmark
Radiology · 26d
Cleared Jul 20, 2009
DRX-EVOLUTION, MODEL VX3733-SYS
K091889 · KPR
Carestream Health, Inc.
Radiology · 26d
Cleared Jul 17, 2009
STARLIGHT
K090587 · OAN
Orthomerica Products, Inc.
Neurology · 135d
Cleared Jul 17, 2009
EASYRA DLDL REAGENT, CALIBRATOR
K090734 · MRR
Medica Corp.
Chemistry · 120d
Cleared Jul 17, 2009
ADHESE ONE F
K090941 · KLE
Ivoclar Vivadent, Inc.
Dental · 105d
Cleared Jul 17, 2009
CHROMID MRSA AGAR, MODEL: REF 43 841
K091024 · JSO
bioMerieux, Inc.
Microbiology · 98d
Cleared Jul 17, 2009
POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
K091296 · NBW
Polymap Wireless
Chemistry · 74d