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
23689–23712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2018
Zenition 70
K183040 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 35d
Cleared Dec 06, 2018
Senhance Surgical System
K183098 · NAY
Transenterix, Inc.
General & Plastic Surgery · 29d
Cleared Dec 06, 2018
Unity Network ID
K183116 · MWI
Ge Healthcare
Cardiovascular · 27d
Cleared Dec 04, 2018
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer...
K180615 · LKN
Fresenius Kabi USA,Llc
Gastroenterology & Urology · 271d
Cleared Dec 04, 2018
Spartan eCoil System
K180653 · HCG
Spartan Micro, Inc.
Neurology · 266d
Cleared Dec 04, 2018
HS50 / HS60 Diagnostic Ultrasound System
K181336 · IYN
Samsung Medison Co., Ltd.
Radiology · 197d
Cleared Dec 04, 2018
CAAS MR Solutions
K181825 · LLZ
Pie Medical Imaging BV
Radiology · 148d
Cleared Dec 04, 2018
Endoform Reconstructive Template - Non Absorbable
K181935 · FTL
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 138d
Cleared Dec 04, 2018
MectaLIF Posterior Extension
K181970 · MAX
Medacta International S.A.
Orthopedic · 133d
Cleared Dec 04, 2018
Elekta Unity
K182076 · IYE
Elekta Limited
Radiology · 125d
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 Nov 30, 2018
Prizma
K173589 · DXH
G-Medical Innovations , Ltd.
Cardiovascular · 375d