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
59953–59976 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2007
ELIBRA DYNAMIC KNEE BALANCER
K070108 · ONN
Synvasive Technology, Inc.
Orthopedic · 83d
Cleared Apr 04, 2007
ZYGOMA IMPLANT (IMMEDIATE FUNCTION)
K070182 · DZE
Nobel Biocare AB
Dental · 75d
Cleared Apr 04, 2007
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
K070221 · KWA
Encore Medical, L.P.
Orthopedic · 70d
Cleared Apr 04, 2007
PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS
K070430 · FPA
Unomedical A/S
General Hospital · 50d
Cleared Apr 04, 2007
BIOLUCENT APPLICATOR KIT
K070659 · JAQ
Biolucent, Inc.
Radiology · 26d
Cleared Apr 03, 2007
SYNFIX -LR
K062083 · MQP
Synthes Spine Co.Lp
Orthopedic · 256d
Cleared Apr 03, 2007
PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
K062963 · GEX
Ra Medical Systems,Inc
General & Plastic Surgery · 186d
Cleared Apr 03, 2007
CORIN UNIPOLAR MODULAR HEAD
K063791 · KWL
Corin USA
Orthopedic · 102d
Cleared Apr 03, 2007
MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM
K070273 · KWQ
Nuvasive, Inc.
Orthopedic · 64d
Cleared Apr 03, 2007
ECHO BI-METRIC PRESS-FIT STEMS
K070274 · KWA
Biomet Manufacturing Corp
Orthopedic · 64d
Cleared Apr 02, 2007
FASTPACK TOTAL PSA METHOD VERIFICATION KIT
K062957 · JJX
Qualigen, Inc.
Immunology · 185d
Cleared Apr 02, 2007
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
K063061 · KNT
Viasys Medsystems
Gastroenterology & Urology · 179d
Cleared Apr 02, 2007
STERILOX LIQUID CHEMICAL STERILANT SYSTEM
K063159 · MED
Puricore, Inc.
General Hospital · 167d
Cleared Apr 02, 2007
RESCUE INTERNAL IMPLANT SYSTEM
K063216 · DZE
Megagen Co., Ltd.
Dental · 160d
Cleared Apr 02, 2007
BLUE SHARK
K070016 · KTT
Meridan Medical
Orthopedic · 89d
Cleared Apr 02, 2007
CONMED LINVATEC SMART GUARD IRRIGATOR
K070233 · HRX
Conmed Linvatec
Orthopedic · 67d
Cleared Apr 02, 2007
LYPHOCHEK DIABETES CONTROL
K070546 · GGM
Bio-Rad Laboratories
Chemistry · 35d
Cleared Apr 02, 2007
C.T.M. MOBILITY SCOOTER# HS-265
K070602 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 28d
Cleared Apr 02, 2007
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
K070644 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 25d
Cleared Apr 02, 2007
WU'S POWERED WHEELCHAIR, MAMBO 36
K070655 · ITI
Wu'S Tech Co., Ltd.
Physical Medicine · 24d
Cleared Apr 02, 2007
FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE
K070673 · GAT
Teleflexmedical, Inc.
General & Plastic Surgery · 21d
Cleared Mar 30, 2007
IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS
K050415 · OBH
Impedimed Pty , Ltd.
Gastroenterology & Urology · 770d
Cleared Mar 30, 2007
CISBIO RENIN RIA TEST
K062120 · CIB
Cis Bio International
Chemistry · 248d
Cleared Mar 30, 2007
D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138
K063321 · NBL
Neks Technologies, Inc.
Dental · 148d