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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
41521–41544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2013
STORM MINI SCREW
K122069 · OAT
Lancer Orthodontics, Inc.
Dental · 269d
Cleared Apr 11, 2013
FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH...
K122239 · JWH
Encore Medical, L.P.
Orthopedic · 258d
Cleared Apr 11, 2013
SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM
K122455 · KTT
Synthes
Orthopedic · 241d
Cleared Apr 11, 2013
SINGLE USE PRELOADED SPHINCTEROTOME V
K122505 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 238d
Cleared Apr 11, 2013
JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
K122812 · BWK
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 210d
Cleared Apr 11, 2013
PASTELLE Q-SWITCHED ND: YAG LASER
K123293 · GEX
Won Technology Co., Ltd.
General & Plastic Surgery · 171d
Cleared Apr 11, 2013
TK1 TOTAL KNEE SYSTEM
K123339 · JWH
Novosource, Inc.
Orthopedic · 162d
Cleared Apr 11, 2013
HEALICOIL SUTURE ANCHOR WITH REGENESORB
K123393 · MAI
Smith & Nephew, Inc.
Orthopedic · 160d
Cleared Apr 11, 2013
STAXX(R) IB SYSTEM
K123461 · MAX
Spine Wave, Inc.
Orthopedic · 153d
Cleared Apr 11, 2013
FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
K123700 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 129d
Cleared Apr 11, 2013
MULTILASER SYSTEM
K123777 · GEX
Ultralight Laser Technologies, LLC
General & Plastic Surgery · 122d
Cleared Apr 11, 2013
PATIENT MONITOR
K130056 · MWI
Ld Technology, LLC
Cardiovascular · 92d
Cleared Apr 11, 2013
EXTREMITY MEDICAL IP FUSION SYSTEM
K130120 · HWC
Extremity Medical, LLC
Orthopedic · 84d
Cleared Apr 11, 2013
SHORT PORT BLUNT TIP TROCAR
K130121 · GCJ
Boston Scientific Corporation
General & Plastic Surgery · 84d
Cleared Apr 11, 2013
S4 SPINAL SYSTEM
K130291 · NKB
Aesculap Implant System, Inc.
Orthopedic · 64d
Cleared Apr 11, 2013
INCITE ANCHORED CERVICAL INTERBODY DEVICE
K130306 · OVE
Incite Innovation, LLC
Orthopedic · 63d
Cleared Apr 11, 2013
EPIC 10S
K130465 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 45d
Cleared Apr 11, 2013
INFINITY CENTRALSTATION WITH INFINITY M300
K130711 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 27d
Cleared Apr 11, 2013
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST...
K130813 · LCJ
Mentor Corp.
General & Plastic Surgery · 17d
Cleared Apr 10, 2013
PENTAX EPK-I5010 VIDEO PROCESSOR
K122470 · PEA
Pentax Medical
Gastroenterology & Urology · 240d
Cleared Apr 10, 2013
ASSURANCE ALAR SENSOR MODEL 10078
K122996 · DQA
Xhale
Anesthesiology · 195d
Cleared Apr 10, 2013
HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY...
K123703 · LCX
Healgen Scientific, LLC
Chemistry · 128d
Cleared Apr 10, 2013
SPINE COIL
K123708 · MOS
Usa Paramed Medical Systems, Inc.
Radiology · 128d
Cleared Apr 10, 2013
STRAUMANN DENTAL IMPLANT SYSTEM
K123784 · DZE
Straumann USA, LLC
Dental · 121d