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
50617–50640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 2010
DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811
K100334 · KDI
B. Braun Avitum AG
Gastroenterology & Urology · 76d
Cleared Apr 22, 2010
NANOSS BONE VOID FILLER
K100361 · MQV
Pioneer Surgical Technology
Orthopedic · 69d
Cleared Apr 22, 2010
DIAMONDBACK SPINAL SYSTEM
K100377 · MNI
Eminent Spine
Orthopedic · 69d
Cleared Apr 22, 2010
PRESTODR PORTABLE
K100400 · IZL
Cmt Medical Technologies, Ltd.
Radiology · 65d
Cleared Apr 22, 2010
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V,...
K100454 · HCG
MicroVention, Inc.
Neurology · 64d
Cleared Apr 22, 2010
AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
K100526 · FPD
Kentec Medical, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 22, 2010
OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
K100803 · FEQ
Keymed, Inc.
Gastroenterology & Urology · 31d
Cleared Apr 22, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100855 · LYZ
Suzhou Shengyuda Plastic Products...
General Hospital · 27d
Cleared Apr 22, 2010
SPECIMEN RETRIEVAL SYSTEM
K100959 · GCJ
Applied Medical Resources
General & Plastic Surgery · 15d
Cleared Apr 21, 2010
SMITH & NEPHEW HIP SYSTEMS WITH HA
K090982 · MEH
Smith & Nephew, Inc.
Orthopedic · 379d
Cleared Apr 21, 2010
ACUPUNCTURE NEEDLES
K092240 · MQX
Haenglim Seowon Medical Co.
General Hospital · 272d
Cleared Apr 21, 2010
NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER...
K100195 · GCJ
Nds Surgical Imaging
General & Plastic Surgery · 89d
Cleared Apr 21, 2010
VENTRIO HERNIA PATCH
K100229 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 85d
Cleared Apr 21, 2010
ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM
K100415 · GEX
Lumenis
General & Plastic Surgery · 64d
Cleared Apr 21, 2010
GTX 12 GIDEWIRE
K100470 · DQX
Medtronic, Inc.
Cardiovascular · 62d
Cleared Apr 21, 2010
MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST
K100789 · DRA
Evalve, Inc.
Cardiovascular · 30d
Cleared Apr 20, 2010
CLEARWAY OTW MODEL 85912
K093431 · DQY
Atrium Medical Corp.
Cardiovascular · 167d
Cleared Apr 20, 2010
TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM
K100155 · DSI
Biomedical Systems Corp.
Cardiovascular · 90d
Cleared Apr 20, 2010
IMC SURGICAL DRAPE
K100208 · KKX
International Medsurg Connection
General Hospital · 85d
Cleared Apr 20, 2010
DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM
K100312 · HSB
Dgimed Ortho, Inc.
Orthopedic · 75d
Cleared Apr 20, 2010
VITAPHONE. MODEL 100 BT
K100383 · DXH
Vitasystems GmbH
Cardiovascular · 63d
Cleared Apr 20, 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY
K100618 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 47d
Cleared Apr 19, 2010
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
K092048 · DJR
Biosite Incorporated
Chemistry · 286d
Cleared Apr 19, 2010
SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR
K100159 · MBI
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 89d