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

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175,820 results
24289–24312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2018
NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture...
K182479 · DHB
Hycor Biomedical
Immunology · 85d
Cleared Dec 04, 2018
Healix™ Compression Screw System
K182949 · HWC
Nvision Biomedical Technologies, LLC
Orthopedic · 42d
Cleared Dec 04, 2018
MOSAIQ Oncology Information System
K183034 · IYE
Elekta, Inc.
Radiology · 33d
Cleared Dec 04, 2018
Monaco RTP System
K183037 · MUJ
Elekta, Inc.
Radiology · 33d
Cleared Dec 04, 2018
Coolrail Linear Pen
K183065 · OCL
AtriCure, Inc.
Cardiovascular · 29d
Cleared Dec 04, 2018
NobelZygoma 0°
K183069 · DZE
Nobel Biocare AB
Dental · 29d
Cleared Dec 04, 2018
6420 Ultrasound System
K183191 · IYN
Esaote, S.P.A.
Radiology · 15d
Cleared Dec 03, 2018
IMPLANTER DENTAL PLANNING SOFTWARE
K173083 · LLZ
Implanter, LLC
Radiology · 430d
Cleared Dec 03, 2018
LZI Fentanyl Enzyme Immunoassay
K181159 · DJG
Lin-Zhi International, Inc.
Toxicology · 216d
Cleared Dec 03, 2018
Action Trackchair
K181908 · ITI
Action Manufacturing, Inc.
Physical Medicine · 139d
Cleared Dec 03, 2018
Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles,...
K182146 · FMI
Sol-Millennium Medical, Inc.
General Hospital · 117d
Cleared Dec 03, 2018
Wondfo T-Cup Multi-Drug Urine Test Cup
K182701 · NFT
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 67d
Cleared Nov 30, 2018
Single Use Hot Biopsy Forceps FD-231
K173495 · QEC
Olympus Medical Systems Corp.
Anesthesiology · 382d
Cleared CT Nov 30, 2018
Prizma
K173589 · DXH
G-Medical Innovations , Ltd.
Cardiovascular · 375d
Cleared Nov 30, 2018
welloStationX
K180298 · FLL
Wello, Inc.
General Hospital · 301d
Cleared Nov 30, 2018
Transcend 365 miniCPAP System
K180388 · BZD
Somnetics International, Inc.
Anesthesiology · 290d
Cleared Nov 30, 2018
ZOLL Propaq M
K180482 · MHX
ZOLL Medical Corporation
Cardiovascular · 280d
Cleared Nov 30, 2018
Tinnitus Sound Generator Module
K180495 · KLW
GN Hearing A/S
Ear, Nose, Throat · 277d
Cleared Nov 30, 2018
Arterial Pressure Monitoring Set/Tray
K180792 · DQO
Cook Incorporated
Cardiovascular · 248d
Cleared Nov 30, 2018
UNO Negative Pressure Wound Therapy System
K180840 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 245d
Cleared Nov 30, 2018
Planmed Verity
K180918 · OAS
Planmed OY
Radiology · 235d
Cleared Nov 30, 2018
BD PhaSeal Optima Closed System Transfer Device
K181221 · ONB
Becton, Dickinson and Company
General Hospital · 207d
Cleared Nov 30, 2018
Ambu aScope RLS Slim
K181286 · EOB
Ambu A/S
Ear, Nose, Throat · 198d
Cleared Nov 30, 2018
Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with...
K181524 · BZC
Vyaire Medical, Inc.
Anesthesiology · 172d