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
57313–57336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2008
KIMBERLY-CLARK INTRODUCER KITS
K080253 · KGC
Kimberly-Clark Corp.
Gastroenterology & Urology · 26d
Cleared Feb 26, 2008
1500 PRO
K080289 · DXN
Omron Healthcare, Inc.
Cardiovascular · 22d
Cleared Feb 26, 2008
NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
K080342 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 18d
Cleared Feb 25, 2008
BIOMERIX SURGICAL MESH, MODEL: RCR-01
K070961 · FTL
Biomerix Corporation
General & Plastic Surgery · 326d
Cleared Feb 25, 2008
YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J
K072860 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 143d
Cleared Feb 25, 2008
FORE-SIGHT, MC-2000 SERIES
K073036 · DQA
Cas Medical Systems, Inc.
Anesthesiology · 119d
Cleared Feb 25, 2008
ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504
K073046 · GEI
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 119d
Cleared Feb 25, 2008
MINITAPE URETHRAL SLING
K073646 · PAH
Mpathy Medical Devices, Ltd.
Gastroenterology & Urology · 61d
Cleared Feb 22, 2008
NONCON ROBO PACHY F&A
K062763 · NQE
Konan Medical, Inc.
Ophthalmic · 525d
Cleared Feb 22, 2008
LEONE ORTHODONTIC MINI IMPLANT
K071490 · OAT
Leone S.P.A.
Dental · 268d
Cleared Feb 22, 2008
FOX 940, MODEL 940
K071896 · GEX
Valam, Inc.
General & Plastic Surgery · 228d
Cleared Feb 22, 2008
NOBELACTIVE ZIRCONIA ABUTMENT
K072129 · NHA
Nobel Biocare AB
Dental · 204d
Cleared Feb 22, 2008
FOX 1-980, FOX Q-1064, FOX-Q-810
K073322 · GEX
A.R.C Laser GmbH
General & Plastic Surgery · 88d
Cleared Feb 22, 2008
SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM
K073466 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 74d
Cleared Feb 22, 2008
NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
K073576 · HBA
Harod Enterprises, Inc.
Neurology · 65d
Cleared Feb 22, 2008
NEOMED SINGLE LUMEN UMBILICAL CATHETER
K073596 · FOS
Neomed, Inc.
General Hospital · 63d
Cleared Feb 22, 2008
XVIEWNET
K080290 · LLZ
American Radiologist Network, Inc.
Radiology · 18d
Cleared Feb 22, 2008
IMAGEGRID
K080333 · LLZ
Candelis, Inc.
Radiology · 15d
Cleared Feb 22, 2008
ZIMMER MIS LIGHT
K080367 · FST
Zimmer Spine, Inc.
General & Plastic Surgery · 10d
Cleared Feb 21, 2008
EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR
K070259 · CCJ
Bedfont Scientific, Ltd.
Anesthesiology · 391d
Cleared Feb 21, 2008
ENSPLINTRX BONE FIXATION SYSTEM
K071809 · HRS
Sonoma Orthopedic Products, Inc.
Orthopedic · 234d
Cleared Feb 21, 2008
AQUA PURE DEIONIZER EXCHANGE SERVICE
K072158 · FIP
Staubach Barror Water Systems, Inc.
Gastroenterology & Urology · 202d
Cleared Feb 21, 2008
VINYL EXAMINATION GLOVE, POWDERED
K072223 · LYZ
Pinnacle Co., Ltd.
General Hospital · 195d
Cleared Feb 21, 2008
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
K072988 · FIB
Nipro Medical Corporation
Gastroenterology & Urology · 121d