FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
34009–34032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2015
Penguin In-Line Warmer
K150484 · LGZ
Creche Innovations
General Hospital · 135d
Cleared Jul 09, 2015
OIC Intramedullary Nail System
K150655 · HSB
Orthopaedic Implant Company
Orthopedic · 118d
Cleared Jul 09, 2015
GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle
K151037 · MBI
Conmed Corporation
Orthopedic · 80d
Cleared Jul 09, 2015
EndoLIF On-Cage
K151143 · MAX
Joimax GmbH
Orthopedic · 71d
Cleared Jul 09, 2015
Aplio 500/400/300 Diagnostic Ultrasound System V6.0
K151451 · IYN
Toshibamedical Systems Corporation
Radiology · 41d
Cleared Jul 09, 2015
Leva Spacer System
K151581 · MAX
Spine Wave, Inc.
Orthopedic · 28d
Cleared Jul 09, 2015
OASYS(r) System
K151755 · NKG
Stryker Corporation
Orthopedic · 10d
Cleared Jul 08, 2015
SterilContainer S System
K142970 · KCT
Aesculap, Inc.
General Hospital · 267d
Cleared Jul 08, 2015
I-Portal NOTC, VNG and VOG
K143607 · GWN
Neuro Kinetics, Inc.
Ear, Nose, Throat · 201d
Cleared Jul 08, 2015
NavSuite3 Kit
K150301 · HAW
Stryker Leibinger GmbH & Co. KG -...
Neurology · 152d
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