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

Filters: Cleared only ×
175,820 results
34609–34632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 2015
EXPAZEN
K150423 · MVL
Produits Dentaires Pierre Rolland...
Dental · 139d
Cleared Jul 08, 2015
JO H20 Water Based Personal Lubricant
K150480 · NUC
United Consortium, Inc.
Obstetrics & Gynecology · 134d
Cleared Jul 08, 2015
Arrow Endurance Extended Dwell Peripheral Catheter System
K151513 · FOZ
Arrow Internation, Inc. (Subsidiary...
General Hospital · 34d
Cleared Jul 08, 2015
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
K151536 · HBG
Mri Interventions, Inc.
Neurology · 30d
Cleared Jul 08, 2015
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I,...
K151552 · JIX
Elitechgroup
Chemistry · 29d
Cleared Jul 07, 2015
LeadCare Plus Blood Lead Testing System
K142705 · DOF
Magellan Diagnostics
Toxicology · 288d
Cleared Jul 07, 2015
mcompass Biofeedback Anorectal Manometry System
K143031 · KLA
Medspira, LLC
Gastroenterology & Urology · 259d
Cleared Jul 07, 2015
Disposable Safety Self-destructive Syringes, 5 ML
K143070 · MEG
Jiangsu Yile Medical Article Co., Ltd.
General Hospital · 253d
Cleared Jul 07, 2015
ANGIO-PRESS DVT Compression Device Model Name: IPCS
K143202 · JOW
Pegasus Medical Supply, Inc.
Cardiovascular · 242d
Cleared Jul 07, 2015
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
K150661 · JDW
Citieffe S.R.L.
Orthopedic · 116d
Cleared Jul 07, 2015
Reform Pedicle Screw System
K150856 · NKB
Precision Spine, Inc.
Orthopedic · 98d
Cleared Jul 07, 2015
Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse...
K150907 · GEX
Ellipse A/S
General & Plastic Surgery · 95d
Cleared Jul 07, 2015
iBond Universal & iBond Ceramic Primer
K150933 · KLE
Heraeus Kulzer, LLC, Mitsui Chemicals...
Dental · 92d
Cleared Jul 07, 2015
Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon...
K151054 · GEH
C2 Therapeutics, Inc.
General & Plastic Surgery · 78d
Cleared Jul 07, 2015
Monaco
K151233 · MUJ
Impac Medical Systems, Inc.
Radiology · 60d
Cleared Jul 07, 2015
Dentrix Ascend Imaging
K151438 · LLZ
Realcloud Imaging, Inc.
Radiology · 39d
Cleared Jul 07, 2015
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
K151488 · NKB
Orthofix, Inc.
Orthopedic · 35d
Cleared Jul 07, 2015
CardioChek Plus Test System
K151530 · CGA
Polymer Technology Systems, Inc.
Chemistry · 29d
Cleared Jul 07, 2015
Graft Delivery Device with Integrated Stylet
K151543 · FMF
Micromedics, Inc. (D/B/A Nordson...
General Hospital · 29d
Cleared Jul 06, 2015
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K143732 · FDF
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 189d
Cleared Jul 06, 2015
Hypervisor IX Monitoring System
K150632 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 117d
Cleared Jul 06, 2015
Electronic Pulse Stimulator
K150995 · NUH
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology · 82d
Cleared Jul 06, 2015
Lariat snare
K151197 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 62d
Cleared Jul 06, 2015
Armada 18 PTA Catheter
K151317 · LIT
Abbott Vascular
Cardiovascular · 49d