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
59761–59784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2007
SAPHENEIA CLARITY
K063391 · LLZ
Sapheneia Commercial Products AB
Radiology · 168d
Cleared Apr 26, 2007
ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
K063582 · KGO
Zimmer, Inc.
General Hospital · 146d
Cleared Apr 26, 2007
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE...
K070249 · CIC
Horiba Abx
Chemistry · 90d
Cleared Apr 26, 2007
DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
K070292 · KXA
Zimmer GmbH
Orthopedic · 85d
Cleared Apr 26, 2007
ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028
K070413 · KLE
CAO Group, Inc.
Dental · 73d
Cleared Apr 26, 2007
ZOLL E SERIES WITH SEE-THRU CPR
K070455 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 69d
Cleared Apr 26, 2007
HYPER SAL
K070498 · CAF
Pari Innovative Manufacturers, Inc.
Anesthesiology · 65d
Cleared Apr 26, 2007
PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).
K070664 · MUH
Progeny, Inc.
Radiology · 48d
Cleared Apr 26, 2007
MEROGEL INJECTABLE BIORESORBABLE STENT
K070886 · NHB
Medtronic, Inc.
Ear, Nose, Throat · 27d
Cleared Apr 25, 2007
ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION
K062332 · LPN
Altaire Pharmaceuticals, Inc.
Ophthalmic · 258d
Cleared Apr 25, 2007
ECHOSTIM FACET TIP
K063380 · BSP
Havel'S, Inc.
Anesthesiology · 168d
Cleared Apr 25, 2007
ARTHROCARE ENT PLASMA WAND
K070374 · GEI
Arthrocare Corp.
General & Plastic Surgery · 76d
Cleared Apr 25, 2007
THEKEN VU MESH VBR SYSTEM
K070381 · MQP
Theken Spine, LLC
Orthopedic · 76d
Cleared Apr 25, 2007
NEWLIFE SCIENCES LLC, MODEL TMR
K070474 · GZJ
Newlife Sciences, LLC
Neurology · 64d
Cleared Apr 25, 2007
DICOMPACS, MODEL 5
K070618 · LLZ
Oehm Und Rehbein GmbH
Radiology · 51d
Cleared Apr 25, 2007
FREEALGIN
K070700 · ELW
Zhermack S.P.A.
Dental · 43d
Cleared Apr 25, 2007
LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK,...
K070848 · JJW
Bio-Rad, Diagnostics Grp.
Chemistry · 28d
Cleared Apr 25, 2007
HSINER NEBULIZER BOTTLE
K070948 · CAF
Hsiner
Anesthesiology · 21d
Cleared Apr 24, 2007
FX DETACHABLE COIL SYSTEM
K060747 · HCG
Micro Therapeutics, Inc.
Neurology · 400d
Cleared Apr 24, 2007
OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050
K062834 · LYC
Genoss Co., Ltd.
Dental · 215d
Cleared Apr 24, 2007
OSSEOTITE
K063286 · DZE
Implant Innovations, Inc.
Dental · 175d
Cleared Apr 24, 2007
ZILOS-TK
K063636 · MRX
Hamilton Thorne Biosciences
Obstetrics & Gynecology · 138d
Cleared Apr 24, 2007
4S SPINAL SYSTEM
K063708 · MNI
Taeyeon Medical Co., Ltd.
Orthopedic · 132d
Cleared Apr 24, 2007
FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N
K070222 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 90d