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
65737–65760 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2005
STELTHSTATION WIRELESS SURGEON MOUSE
K051029 · HAW
Medtronic Surgical Navigation
Neurology · 47d
Cleared Jun 08, 2005
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
K051125 · FZP
Abbott Laboratories
General & Plastic Surgery · 36d
Cleared Jun 08, 2005
EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150
K051179 · NFA
Boston Scientific Corp
Cardiovascular · 30d
Cleared Jun 08, 2005
REXEED SERIES DIALYZERS
K051187 · KDI
Asahi Kasei Medical Co., Ltd.
Gastroenterology & Urology · 30d
Cleared Jun 08, 2005
PREVAIL DENTAL IMPLANTS
K051189 · DZE
Implant Innovations, Inc.
Dental · 29d
Cleared Jun 08, 2005
ON TRAK TESTCARD
K051235 · DKZ
Varian, Inc.
Chemistry · 26d
Cleared Jun 08, 2005
PRECEDENCE SPECT/CT IMAGING SYSTEM
K051351 · KPS
Adac Laboratories
Radiology · 15d
Cleared Jun 08, 2005
REMOTE CARE MANAGEMENT SYSTEMS (RCMS)
K051470 · DRG
Bl Healthcare, Inc.
Cardiovascular · 5d
Cleared Jun 07, 2005
SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM
K031196 · HAW
Praxim
Neurology · 783d
Cleared Jun 07, 2005
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
K050277 · LYY
Hartalega Sdn Bhd
General Hospital · 120d
Cleared Jun 07, 2005
MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER
K050371 · DQO
Medrad, Inc.
Cardiovascular · 113d
Cleared Jun 07, 2005
PROTECT TOOTH DESENSITIZER
K050486 · LBH
Sunstar Butler
Dental · 102d
Cleared Jun 07, 2005
IMC DRAPES
K050538 · KKX
Intl. Medsurg Connection, Inc.
General Hospital · 97d
Cleared Jun 07, 2005
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]
K050915 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 56d
Cleared Jun 07, 2005
IBOND NEXT GENERATION
K051006 · KLE
Heraeus Kulzer,GmbH
Dental · 48d
Cleared Jun 07, 2005
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
K051103 · HJK
Haag-Streit USA, Inc.
Ophthalmic · 39d
Cleared Jun 07, 2005
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH PLASTICIZER EBN&BET
K051166 · LYZ
Gloveco, Inc.
General Hospital · 33d
Cleared Jun 07, 2005
KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE
K051347 · LZA
Kimberly-Clark Corp.
General Hospital · 14d
Cleared Jun 06, 2005
COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
K043296 · FRO
Covalontechnologies, Inc.
General & Plastic Surgery · 189d
Cleared Jun 06, 2005
SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR
K043306 · ILY
Skylark Device & Systems Co., Ltd.
Physical Medicine · 187d
Cleared Jun 06, 2005
REPROCESSED ULTRASONIC SCALPELS
K043358 · NLQ
Alliance Medical Corp.
General & Plastic Surgery · 182d
Cleared Jun 06, 2005
XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A
K043558 · ILY
Chongqing Xinfeng Medical Instruments...
Physical Medicine · 161d
Cleared Jun 06, 2005
CENTERPIECE PLATE FIXATION SYSTEM
K050082 · NQW
Medtronic Sofamor Danek, Inc.
Orthopedic · 144d
Cleared Jun 06, 2005
IMMEDIA PROTHROMBIN TIME SYSTEM
K050243 · JPA
Farallon Medial, Inc.
Hematology · 124d