FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
20833–20856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2020
TGS Universal Headrest with Mounting Arm
K193502 · PGW
Stryker Ent
Ear, Nose, Throat · 58d
Cleared Feb 14, 2020
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
K193567 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Feb 14, 2020
E-COM DR-2000 DR
K193644 · MQB
Livermoretech, Inc.
Radiology · 46d
Cleared Feb 14, 2020
EMBA Hourglass Peripheral Embolization Device (PED)
K200083 · KRD
Embolic Acceleration, LLC
Cardiovascular · 30d
Cleared Feb 13, 2020
Implacil Implant System
K183024 · DZE
Implacil DE Bortoli Material...
Dental · 469d
Cleared Feb 13, 2020
XenoSure Biologic Patch
K190882 · PSQ
Lemaitre Vascular
General & Plastic Surgery · 315d
Cleared Feb 13, 2020
ArtiSential Bipolar Fenestrated Forceps
K190909 · GEI
Livsmed, Inc.
General & Plastic Surgery · 311d
Cleared Feb 13, 2020
EleGARD Patient Positioning System
K191689 · FOA
Minnesota Resuscitation Solutions,...
General Hospital · 233d
Cleared Feb 13, 2020
Vathin Video Bronchoscope System
K191828 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 220d
Cleared Feb 13, 2020
Microlife Non-Contact Infrared Forehead Thermometer
K191829 · FLL
Microlife Intellectual Property GmbH
General Hospital · 219d
Cleared Feb 13, 2020
NewPrim System
K191966 · KWH
Brm Extremities
Orthopedic · 205d
Cleared Feb 13, 2020
DiaTemp Flow
K192022 · EBG
DiaDent Group International
Dental · 199d
Cleared Feb 13, 2020
DiaTemp
K192158 · EBG
DiaDent Group International
Dental · 188d
Cleared Feb 13, 2020
LED Curing Light
K192233 · EBZ
Foshan Cicada Dental Instrument Co, Ltd.
Dental · 178d
Cleared Feb 13, 2020
Praxiject 0.9% NaCl
K192414 · NGT
Medxl, Inc.
General Hospital · 162d
Cleared Feb 13, 2020
Youjia Unscented Tampon with Plastic Applicators
K192557 · HEB
Qingdao Youjia Hygiene Technology...
Obstetrics & Gynecology · 149d
Cleared Feb 13, 2020
Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment
K192614 · NHA
Megagen Implant Co., Ltd.
Dental · 143d
Cleared Feb 13, 2020
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
K192828 · JAK
Canon Medical Systems Corporation
Radiology · 134d
Cleared Feb 13, 2020
Agilon Moldable
K193168 · MQV
Biogennix, LLC
Orthopedic · 90d
Cleared Feb 13, 2020
Daytona® Small Stature Growth Rod Conversion Set
K193224 · PGM
SeaSpine Orthopedics Corporation
Orthopedic · 83d
Cleared Feb 13, 2020
Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation...
K193232 · NEY
Covidien, LLC
General & Plastic Surgery · 80d
Cleared Feb 13, 2020
OrthoCircle Spine Pedicle Screw System
K193472 · NKB
Orthocircle Spine
Orthopedic · 59d
Cleared Feb 13, 2020
ADVIA Centaur BR
K193489 · MOI
Siemens Healthcare Diagnostics, Inc.
Immunology · 58d
Cleared Feb 13, 2020
Infinitt RT PACS
K193498 · LLZ
Infinitt Healthcare Co., Ltd.
Radiology · 58d