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
11617–11640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2022
Caduceus S
K220554 · SBF
Taiwan Main Orthopaedic Biotechnology...
Orthopedic · 291d
Cleared Dec 16, 2022
Overjet Calculus Assist
K220928 · MYN
Overjet, Inc.
Radiology · 260d
Cleared Dec 16, 2022
Saige-Density
K222275 · QIH
DeepHealth, Inc.
Radiology · 140d
Cleared Dec 16, 2022
KLICK (VARIANTS: POWER, RACE, MONSTER)
K222502 · ITI
Klaxon Mobility GmbH
Physical Medicine · 120d
Cleared Dec 16, 2022
Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
K222608 · FLE
Tuttnauer , Ltd.
General Hospital · 109d
Cleared Dec 16, 2022
Rejoni Intrauterine Catheter
K222798 · LKF
Rejoni, Inc.
Obstetrics & Gynecology · 91d
Cleared Dec 16, 2022
BRM TOOL Screws, BIOPLAN Subtalar Implant
K222820 · HWC
Brm Extremities
Orthopedic · 88d
Cleared Dec 16, 2022
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
K223153 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d
Cleared Dec 16, 2022
Phantom Metatarsal Shortening System
K223184 · HWC
Paragon 28, Inc.
Orthopedic · 65d
Cleared Dec 16, 2022
SofWave System
K223237 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 58d
Cleared Dec 16, 2022
BD Microtainer® Contact-Activated Lancets
K223243 · FMK
Becton, Dickinson and Company
General & Plastic Surgery · 57d
Cleared Dec 16, 2022
Hexanium PLIF
K223251 · MAX
Spinevision, S.A.S.
Orthopedic · 56d
Cleared Dec 16, 2022
BrainInsight
K223268 · QIH
Hyperfine, Inc.
Radiology · 53d
Cleared Dec 16, 2022
Sterile Hypodermic Needles for Single Use
K223334 · FMI
Zhejiang Kindly Medical Devices Co.,...
General Hospital · 45d
Cleared Dec 15, 2022
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright...
K214086 · ELW
Genoss Co., Ltd.
Dental · 353d
Cleared Dec 15, 2022
PM Excellence SEQUR 100 Surgical Face Mask
K220520 · FXX
Pm Excellence, LLC
General Hospital · 295d
Cleared Dec 15, 2022
Proxima
K220591 · NFB
Dynasthetics, LLC
Anesthesiology · 289d
Cleared Dec 15, 2022
Perceptive electric dental motor and control unit
K220873 · EIA
Lares Research
Dental · 265d
Cleared Dec 15, 2022
Small Field Applicator
K220883 · LHN
Hitachi, Ltd. Radiation Oncology...
Radiology · 265d
Cleared Dec 15, 2022
LOTUS Series 4 Enhanced Shears, LOTUS Series 5
K221102 · LFL
Sra Developments, Ltd.
General & Plastic Surgery · 245d
Cleared Dec 15, 2022
VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor
K221267 · MWI
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 227d
Cleared Dec 15, 2022
S.I.N. Dental Implant System
K221453 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 210d
Cleared Dec 15, 2022
Dozee VS
K221555 · BZQ
Turtle Shell Technologies Private...
Anesthesiology · 198d
Cleared Dec 15, 2022
Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with...
K222892 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 83d