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

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176,076 results
55249–55272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2008
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
K080944 · LJE
C.R. Bard, Inc.
Gastroenterology & Urology · 203d
Cleared Oct 23, 2008
PROFILE MULTI-PLATFORM SYSTEM
K081352 · GEX
Sciton, Inc
General & Plastic Surgery · 162d
Cleared Oct 23, 2008
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786
K081382 · KYB
Duckworth & Kent, Ltd.
Ophthalmic · 160d
Cleared Oct 23, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS...
K081543 · JLW
Ortho-Clinical Diagnostics, Inc.
Chemistry · 143d
Cleared Oct 23, 2008
AERONEB GO NEBULIZER
K081650 · CAF
Aerogen (Ireland), Ltd.
Anesthesiology · 133d
Cleared Oct 23, 2008
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
K082139 · DXZ
Edwards Lifesciences, LLC
Cardiovascular · 86d
Cleared Oct 23, 2008
FLASH N' GO
K082298 · GEX
Home Skinovations , Ltd.
General & Plastic Surgery · 72d
Cleared Oct 23, 2008
MEDICAL DISPLAY, MD205MG-1
K082493 · LLZ
Nec Display Solutions , Ltd.
Radiology · 55d
Cleared Oct 23, 2008
K-PACK II NEEDLE - 29G THIN WALL
K082820 · FMI
Terumo Europe N.V.
General Hospital · 28d
Cleared Oct 23, 2008
AMSELF CLOSED CATHETERIZATION SYSTEM
K082831 · FCM
Amsino International, Inc.
Gastroenterology & Urology · 27d
Cleared Oct 23, 2008
MODIFICATION TO ZENIEVA
K082865 · NAE
Gorbec Pharmaceutical Services, Inc.
General & Plastic Surgery · 24d
Cleared Oct 23, 2008
LUMINEX INFRARED LAMP SYSTEM
K082969 · ILY
Medical Laser Systems, Inc.
Physical Medicine · 17d
Cleared Oct 22, 2008
EVOLIS TOTAL KNEE SYSTEM
K081023 · JWH
Medacta International S.A.
Orthopedic · 195d
Cleared Oct 22, 2008
INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES
K081436 · FMF
Inviro Medical Devices, Inc.
General Hospital · 154d
Cleared Oct 22, 2008
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II
K082088 · KRR
Mako Surgical Corp.
Orthopedic · 90d
Cleared Oct 22, 2008
RAYDOSE
K082221 · MUJ
Raysearch Laboratories AB
Radiology · 77d
Cleared Oct 22, 2008
ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
K082513 · NBW
Lifescan, Inc.
Chemistry · 50d
Cleared Oct 22, 2008
OMRON MODEL HBP-2070 VITAL SIGNS MONITOR
K082812 · MWI
Omron Healthcare, Inc.
Cardiovascular · 28d
Cleared Oct 22, 2008
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K082822 · LYZ
Zibo Zhuangyuan Plastic Products Company
General Hospital · 27d
Cleared Oct 22, 2008
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K083001 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 14d
Cleared Oct 22, 2008
GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE
K083019 · FRN
Hospira, Inc.
General Hospital · 13d
Cleared Oct 21, 2008
SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004...
K073645 · DZE
659543 BC , Ltd.
Dental · 300d
Cleared Oct 21, 2008
ALCOHOL PAD
K080466 · QBP
122 Corporation
General Hospital · 243d
Cleared Oct 21, 2008
1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2
K080877 · MEG
Unilife Medical Solutions Limited
General Hospital · 204d