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

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175,820 results
140329–140352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1987
MINGOGRAF 740 - MODEL #91-54-634
K864575 · LOS
Siemens Medical Solutions USA, Inc.
Cardiovascular · 168d
Cleared May 07, 1987
NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT
K870187 · LJT
Norfolk Medical Products, Inc.
General Hospital · 111d
Cleared May 07, 1987
HEATED INSTRUMENT BATH
K870276 · LRJ
Simpson/Basye, Inc.
General Hospital · 100d
Cleared May 07, 1987
AMERICAN ALCOHOL PREP PAD STERILE MEDIUM
K870718 · LKB
Span-America Medical Systems, Inc.
General Hospital · 76d
Cleared May 07, 1987
CLEANING SOLUTION, CATALOG NO. 8203
K870759 · LRJ
Treace Medical, Inc.
General Hospital · 70d
Cleared May 07, 1987
LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1
K871245 · LQJ
Chiron Vision Corp.
Ophthalmic · 41d
Cleared May 07, 1987
CARIESCREEN LB
K871264 · JSJ
Apo Diagnostics, Inc.
Microbiology · 37d
Cleared May 07, 1987
SITE PERISTALTIC MODULE SYSTEM
K871375 · HQE
Site Microsurgical Systems, Inc.
Ophthalmic · 30d
Cleared May 07, 1987
NAMIC COURNAND STYLE INTRODUCER NEEDLE
K871377 · DRC
North American Instrument Corp.
Cardiovascular · 30d
Cleared May 07, 1987
CPU-1 INTENSIVE CARE VENTILATOR
K871398 · CBK
Ohmeda Medical
Anesthesiology · 30d
Cleared May 07, 1987
KRATZ NOVA-SERT
K871440 · KYB
CooperVision, Inc.
Ophthalmic · 24d
Cleared May 07, 1987
MODEL 105 VENTILATOR
K871448 · CBK
Developmed Corp.
Anesthesiology · 24d
Cleared May 07, 1987
SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS
K871478 · FSM
Procedure Pak, Inc.
General & Plastic Surgery · 23d
Cleared May 07, 1987
SURGICAL CAMERA ACCESSORIES
K871595 · KQM
M.P. Video, Inc.
General & Plastic Surgery · 13d
Cleared May 06, 1987
VASOPULSE(TM)/MODEL 5000
K863803 · JOM
Sonicaid, Inc.
Cardiovascular · 219d
Cleared May 06, 1987
CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3
K864456 · LAS
Cala Diagnostics
Toxicology · 174d
Cleared May 06, 1987
ADDITIONAL USE FOR ECG DISPOSABLE ELECTRODE V-PAD
K864690 · DRX
Multi Biosensors, Inc.
Cardiovascular · 155d
Cleared May 06, 1987
INVIVO PULSE OXIMETER, MODEL 4500
K864730 · DQA
Invivo Research Labs, Inc.
Anesthesiology · 153d
Cleared May 06, 1987
CORDAY CORONARY SINUS INFUSION CATHETER
K865074 · DQY
Retroperfusion Systems, Inc.
Cardiovascular · 128d
Cleared May 06, 1987
BONE PLATE
K870082 · HRS
Terray Manufacturing, Inc.
Orthopedic · 118d
Cleared May 06, 1987
MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER
K870301 · DRS
Medex, Inc.
Cardiovascular · 98d
Cleared May 06, 1987
AMBULATORY INFUSION PUMP DRUG RESERVOIR
K870524 · FRN
Med Fusion Systems, Inc.
General Hospital · 89d
Cleared May 06, 1987
OVU-TRAC OVULATION TIMING KIT
K870528 · LHD
Ob/Gyn Concepts, Ltd.
Obstetrics & Gynecology · 90d
Cleared May 06, 1987
THE KEEPER
K870803 · HHE
The Keeper Co.
Obstetrics & Gynecology · 68d