Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Cleared only ×
175,820 results
146233–146256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1985
OSM3 HEMOXIMETER
K853990 · JKS
Radiometer America, Inc.
Chemistry · 94d
Cleared Dec 30, 1985
THE NEW MOBILE TIP MCINTYRE CANNULA
K854401 · HMX
Microsurgical Technology, Inc.
Ophthalmic · 60d
Cleared Dec 30, 1985
THE NEW MCINTYRE I.A. HANDPIECE
K854402 · HMX
Microsurgical Technology, Inc.
Ophthalmic · 60d
Cleared Dec 30, 1985
KEELER-COMPACT CRYO SYSTEM
K854411 · HQA
Keeler Instruments, Inc.
Ophthalmic · 59d
Cleared Dec 30, 1985
SERIES 25 SLIMLINE CRYO PROBES
K854422 · HQA
Keeler Instruments, Inc.
Ophthalmic · 56d
Cleared Dec 30, 1985
RAMP URINE HCG ASSAY
K854611 · JHI
Monoclonal Antibodies, Inc.
Chemistry · 42d
Cleared Dec 30, 1985
DART CK-MB REAGENT SYSTEM
K854708 · JHS
Coulter Electronics, Inc.
Chemistry · 38d
Cleared Dec 30, 1985
LECTROSTILL DISTILLED WATER U.S.P.
K854764
Electrified Companies, Inc.
Ophthalmic · 33d
Cleared Dec 27, 1985
EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS
K852178 · CAC
American Omni Medical, Inc.
Anesthesiology · 221d
Cleared Dec 27, 1985
SATALEC SERVOTOME
K852522 · EKZ
Spelna, Inc.
Dental · 196d
Cleared Dec 27, 1985
MODEL M HEARING AID
K852656 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 186d
Cleared Dec 27, 1985
SPECULITE DISPOSABLE VAGINAL LIGHT
K853257 · HIC
Trylon Associates, Ltd.
Obstetrics & Gynecology · 147d
Cleared Dec 27, 1985
VICON (MODIFICATION)
K853804 · IKN
Oxford Metrics, Inc.
Neurology · 107d
Cleared Dec 27, 1985
P.M. HIP-FEMORAL PROSTHESIS
K853916 · JDI
Advanced Biosearch Assn.
Orthopedic · 95d
Cleared Dec 27, 1985
HI-TECH LAB MODEL CONCHA ALL IN EAR
K853967 · ESD
Hi-Tech Laboratories, Inc.
Ear, Nose, Throat · 92d
Cleared Dec 27, 1985
MODULAR POWER BASE
K854051 · ITI
Everest & Jennings, Inc.
Physical Medicine · 85d
Cleared Dec 27, 1985
PLACIDO DISC
K854054 · HLR
Cutler Medical Instruments
Ophthalmic · 85d
Cleared Dec 27, 1985
PHACO PACKS, 1A PACKS & PACK COMPONENTS
K854116 · HQC
Medical Corp. of America
Ophthalmic · 80d
Cleared Dec 27, 1985
BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL
K854147 · IOL
Battle Creek Equipment Co.
Physical Medicine · 77d
Cleared Dec 27, 1985
MARATHON POWER DRIVE-WHEELCHAIR
K854153 · ITI
Everest & Jennings, Inc.
Physical Medicine · 77d
Cleared Dec 27, 1985
ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS
K854225 · HQC
Advanced Medical Technology, Inc.
Ophthalmic · 70d
Cleared Dec 27, 1985
GDC 1453 CASTING ALLOY
K854285 · EJH
Deringer-Ney, Inc.
Dental · 63d
Cleared Dec 27, 1985
HYBRID POINTS
K854347 · DZP
Shofu Dental Corp.
Dental · 59d
Cleared Dec 27, 1985
COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
K854375 · HQC
CooperVision, Inc.
Ophthalmic · 58d