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
63169–63192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 2006
ACUTE CARE FACE MASK, MODEL RT040
K060044 · MNT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 90d
Cleared Apr 06, 2006
AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
K060309 · DSP
Arrow Intl., Inc.
Cardiovascular · 58d
Cleared Apr 06, 2006
ROTATING GAMMA SYSTEM. GAMMA ART-6000
K060314 · IWB
American Radiosurgery, Inc.
Radiology · 57d
Cleared Apr 06, 2006
EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT
K060385 · MLM
Dade Behring, Inc.
Chemistry · 51d
Cleared Apr 06, 2006
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK...
K060548 · DHA
Dade Behring, Inc.
Chemistry · 36d
Cleared Apr 06, 2006
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
K060628 · CIG
Dade Behring, Inc.
Chemistry · 28d
Cleared Apr 06, 2006
DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS
K060638 · NQP
Zimmer Spine, Inc.
Orthopedic · 27d
Cleared Apr 06, 2006
VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314
K060650 · LCP
Ortho-Clinical Diagnostics, Inc.
Chemistry · 24d
Cleared Apr 06, 2006
HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
K060714 · HWC
Conmed Linvatec
Orthopedic · 20d
Cleared Apr 06, 2006
TONOMETER DIATON
K060780 · HKX
Ryazan State Instruments
Ophthalmic · 15d
Cleared Apr 05, 2006
VYGON LEADER-FLEX
K052564 · FOZ
Vygon Corp.
General Hospital · 198d
Cleared Apr 05, 2006
TRAM MODULE
K053121 · MHX
Ge Healthcare
Cardiovascular · 149d
Cleared Apr 05, 2006
OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M
K053407 · CCL
Analytical Industries, Inc.
Anesthesiology · 119d
Cleared Apr 05, 2006
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K053478 · DZE
Northern Implants, LLC
Dental · 112d
Cleared Apr 05, 2006
LASERTX - DIODE LASER & DELIVERY SYSTEM
K060326 · GEX
Prosurg, Inc.
General & Plastic Surgery · 55d
Cleared Apr 05, 2006
TREK S NEBULIZER COMPRESSOR
K060357 · CAF
Pari Innovative Manufacturers, Inc.
Anesthesiology · 51d
Cleared Apr 05, 2006
MINXRAY, MODELS HFP24 AND HFP40
K060566 · IZL
Mikasa X-Ray Co., Ltd.
Radiology · 33d
Cleared Apr 05, 2006
PTS PANELS HDL CHOLESTEROL TEST STRIPS
K060617 · NAQ
Polymer Technology Systems, Inc.
Chemistry · 28d
Cleared Apr 05, 2006
SWIRLGRAFT VASCULAR ACCESS GRAFT
K060741 · DSY
Veryan Medical Limited
Cardiovascular · 16d
Cleared Apr 05, 2006
ADVANCE VESSEL ANALYSIS II
K060779 · JAK
Ge Healthcare
Radiology · 14d
Cleared Apr 04, 2006
DICK'S FORMALWEAR MALE LATEX CONDOM
K050913 · HIS
Dick'S Formalwear, Inc.
Obstetrics & Gynecology · 357d
Cleared Apr 04, 2006
VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
K051438 · JOW
Alliance Medical, Inc.
Cardiovascular · 307d
Cleared Apr 04, 2006
IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7
K052319 · MNW
Impedimed Pty , Ltd.
Gastroenterology & Urology · 222d
Cleared Apr 04, 2006
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
K053388 · CBK
Puritan Bennett Corp.
Anesthesiology · 120d