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
34585–34608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 2015
Aeroneb USB Contoller System
K143719 · CAF
Aerogen Limited
Anesthesiology · 193d
Cleared Jul 10, 2015
CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear,...
K150590 · LPL
Contamac, Ltd.
Ophthalmic · 123d
Cleared Jul 10, 2015
Atrax Anterior Cervical Plating System
K150834 · KWQ
X-Spine Systems, Inc.
Orthopedic · 102d
Cleared Jul 10, 2015
Houva-NET Control System
K150912 · FTC
National Biological Corporation
General & Plastic Surgery · 98d
Cleared Jul 10, 2015
HARMONIC Focus Long Shears + Adaptive Tissue Technology
K151340 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 52d
Cleared Jul 10, 2015
Abbott ARCHITECT Total T4 Calibrators
K151566 · JIT
Abbott Laboratories
Chemistry · 30d
Cleared Jul 10, 2015
Penumbra Smart Coil
K151572 · HCG
Penumbra, Inc.
Neurology · 29d
Cleared Jul 09, 2015
VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M,...
K141133 · LYR
BIOMERIEUX
Microbiology · 434d
Cleared Jul 09, 2015
BONGOLD BONE GRAFT MATERIAL
K141725 · MQV
Beijing Allgens Medical Science &...
Orthopedic · 378d
Cleared Jul 09, 2015
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
K142764 · CBP
Hangzhou Jinlin Medical Appliances...
Anesthesiology · 287d
Cleared Jul 09, 2015
Model BT-220L and BT-220C
K142799 · HGM
Bistos Co., Ltd.
Obstetrics & Gynecology · 283d
Cleared Jul 09, 2015
Powder Free Vinyl Patient Examination Gloves, Yellow Color
K143340 · LYZ
Zibo Ling Yun Medical Products Co, Ltd.
General Hospital · 230d
Cleared Jul 09, 2015
StarCeram® Z-Nature, StarCeram® Z-Smile
K143656 · EIH
H.C. Starck Ceramics GmbH
Dental · 198d
Cleared Jul 09, 2015
Ablation Confirmation
K150313 · LLZ
Neuwave Medical, Inc.
Radiology · 150d
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