FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
143137–143160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 1986
MS-139 ELECTRONIC MUSCLE STIMULATOR
K862487 · IPF
Electro Med Supply, Inc.
Physical Medicine · 16d
Cleared Jul 16, 1986
FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)
K862507 · CHH
Sclavo, Inc.
Chemistry · 15d
Cleared Jul 16, 1986
IMMPULSE PHENOBARBITAL ASSAY REAGENTS
K862528 · LGQ
Sclavo, Inc.
Toxicology · 14d
Cleared Jul 16, 1986
HEARING AID (ALL-IN-EAR)
K862545 · ESD
Vibrasonic, Inc.
Ear, Nose, Throat · 13d
Cleared Jul 16, 1986
IMMPULSE PHENYTOIN ASSAY REAGENT
K862554 · LGR
Sclavo, Inc.
Toxicology · 13d
Cleared Jul 16, 1986
ULTRAMARK 1 ULTRASOUND SYSTEM
K862681 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 1d
Cleared Jul 15, 1986
PINNACLE MULTI-PROGRAMMABLE PACING SYS
K853771 · DXY
Cardio-Pace Medical, Inc.
Cardiovascular · 309d
Cleared Jul 15, 1986
SIEMENS SIRECUST MODELS 403P,403-2P & 403N
K855096 · DPS
Analogic Corp.
Cardiovascular · 204d
Cleared Jul 15, 1986
THE KEYMED FIBERSCOPE STERILIZATION CASE
K860528 · KCT
Keymed, Inc.
General Hospital · 154d
Cleared Jul 15, 1986
UNICARE BREAST SHELLS
K861608 · HFS
Unicare Medical Products, Inc.
General Hospital · 77d
Cleared Jul 15, 1986
TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024)
K861618 · KNT
Travenol Laboratories, S.A.
Gastroenterology & Urology · 77d
Cleared Jul 15, 1986
DELIVERY ROOM WARMER
K861781 · FMT
Air-Shields, Inc.
General Hospital · 68d
Cleared Jul 15, 1986
EMPI MODEL GLS 450, TENS
K861830 · GZJ
Empi
Neurology · 63d
Cleared Jul 15, 1986
BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR
K861977 · KZD
Biomedical Dynamics, Inc.
General Hospital · 55d
Cleared Jul 15, 1986
STATIC STRENGTH TESTER
K862096 · IKK
Lowcountry Orthopaedic Assoc., P.A.
Physical Medicine · 43d
Cleared Jul 15, 1986
BOMDAL TRAVELMASTER LIFT
K862146 · FNG
Bomdal Medical Equipment, Inc.
General Hospital · 41d
Cleared Jul 15, 1986
BOMDAL STANDARD LIFT
K862147 · FNG
Bomdal Medical Equipment, Inc.
General Hospital · 41d
Cleared Jul 15, 1986
HIP CONTINUOUS PASSIVE MOTION MACHINE
K862314 · BXB
Richards Medical Co., Inc.
Physical Medicine · 27d
Cleared Jul 15, 1986
RUNAROUND
K862405 · ITI
Everest & Jennings, Inc.
Physical Medicine · 20d
Cleared Jul 15, 1986
HALL STERILE BUR
K862529 · HTT
Hall Surgical, Division of Zimmer, Inc.
Orthopedic · 13d
Cleared Jul 15, 1986
DYNEX CO2/2000, CO2 ANALYZER
K862543 · CCK
Analytical Products, Inc.
Anesthesiology · 12d
Cleared Jul 15, 1986
ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE
K862549 · KRI
American Bentley
Cardiovascular · 12d
Cleared Jul 15, 1986
CARBOSTAT, CO2 ANALYZER
K862559 · CCK
Elm Street Designs
Anesthesiology · 12d
Cleared Jul 15, 1986
TRACHEOSTOMY CLEANSING SOLUTION
K862563 · EPE
Clinipad Corp.
Anesthesiology · 12d