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
144601–144624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1986
SHILEY SLEEP APNEA CUFFLESS TRACHEOSTOMY TUBE
K861462 · BTR
Shiley, Inc.
Anesthesiology · 15d
Cleared May 06, 1986
SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE
K861463 · BTR
Shiley, Inc.
Anesthesiology · 15d
Cleared May 06, 1986
MODEL 63-654 THERMOMETER, ELECTRONICS, CLINICAL
K861473 · FLL
Radio Shack Div. Tandy Corp.
General Hospital · 14d
Cleared May 06, 1986
CHARCOAL AGAR BASE
K861480 · JSG
Gibco Laboratories Life Technologies,...
Microbiology · 14d
Cleared May 06, 1986
COMPANION 2800 VOLUME VENTILATOR REMOTE ALARM
K861488 · CBK
Puritan Bennett Corp.
Anesthesiology · 27d
Cleared May 06, 1986
PERMACLEAR SOLUTION CAT. NO. 4950
K861490 · KEM
Helena Laboratories
Pathology · 14d
Cleared May 06, 1986
DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS
K861525 · FSM
D & D Products, Inc.
General & Plastic Surgery · 18d
Cleared May 05, 1986
STETHOSCOPE ELECTRONIC STETHOSCOPE SPHYGMOMANOMETE
K854356 · DQD
Fontaine Industries, Inc.
Cardiovascular · 188d
Cleared May 05, 1986
MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER
K860435 · DPT
Multigon Industries, Inc.
Cardiovascular · 90d
Cleared May 05, 1986
VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM
K860465 · CIT
Abbott Laboratories
Chemistry · 88d
Cleared May 05, 1986
MINI-CHEM ANALYZER
K860987 · JJQ
Ocean Scientific, Inc.
Chemistry · 49d
Cleared May 05, 1986
CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST
K861082 · DYB
Cordis Corp.
Cardiovascular · 45d
Cleared May 05, 1986
MODEL K110SX CENTRIFUGE
K861146 · JQC
Jouan S.A.
Chemistry · 40d
Cleared May 05, 1986
PHARMASEAL DUAL LUMEN CATHETER
K861165 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 38d
Cleared May 05, 1986
THE JR. PARTNER SPECTROPHOTOMETER
K861223 · JJQ
Pharmacia, Inc.
Chemistry · 34d
Cleared May 05, 1986
TAMPER PROOF CAP
K861276 · FMF
Intl. Medical Industries
General Hospital · 28d
Cleared May 05, 1986
SYNCARE TEMPORARY CARDIAC PACING WIRE
K861409 · LDF
Gyneco, Inc.
Cardiovascular · 20d
Cleared May 05, 1986
ULTRACLONE 01-700 CELL LINE
K861569 · KIR
Earl-Clay Laboratories, Inc.
Pathology · 7d
Cleared May 02, 1986
595 ARRHYTHMIA MONITORING SYSTEM
K852250 · DSI
Burdick Corp.
Cardiovascular · 344d
Cleared May 02, 1986
ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY
K853878 · GEX
Endo Lase, Inc.
General & Plastic Surgery · 227d
Cleared May 02, 1986
IMT ULTRASONIC STRIDE MONITOR
K854194
Innovative Medical Technologies, Inc.
Physical Medicine · 199d
Cleared May 02, 1986
ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES
K854231 · GEI
Clinical Technology Corp.
General & Plastic Surgery · 193d
Cleared May 02, 1986
HOOK PROBE
K854890 · KDC
Euro-Med Intl.
General & Plastic Surgery · 147d
Cleared May 02, 1986
KNIFE
K854891 · EMF
Euro-Med Intl.
General & Plastic Surgery · 147d