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
142225–142248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1986
RAYLOR(TM) OSTEOTOMES
K864423
Cedar Surgical, Inc.
Orthopedic · 14d
Cleared Nov 24, 1986
MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY
K864461 · DWS
Medsurg Industries, Inc.
Cardiovascular · 12d
Cleared Nov 24, 1986
SPACELABS ARRHYTHMIA NET (TM) LEVEL 2
K864505 · DSI
Spacelabs, Inc.
Cardiovascular · 10d
Cleared Nov 22, 1986
EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES
K864011 · NAD
Fraass Survival Systems, Inc.
General & Plastic Surgery · 38d
Cleared Nov 21, 1986
PREGELLED DISPOS. ELECT., SILVER-SILVER CHLORIDE
K863366 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 79d
Cleared Nov 21, 1986
LIFE-WATCH MONITOR LT-8
K863534 · DRT
Computerized Medical Systems, Inc.
Cardiovascular · 71d
Cleared Nov 21, 1986
NELLCOR N-200 (PULSE OXIMETER)
K863784 · DQA
Nellcor, Inc.
Anesthesiology · 56d
Cleared Nov 21, 1986
CREST CERVICAL TRACTION
K863838
Central Equipment Sales, Inc.
Physical Medicine · 51d
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM
K863859 · JLW
Hybritech, Inc.
Chemistry · 49d
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN
K863860 · CFT
Hybritech, Inc.
Chemistry · 49d
Cleared Nov 21, 1986
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA
K863861 · JHI
Hybritech, Inc.
Chemistry · 49d
Cleared Nov 21, 1986
LYOFOAM C ODOR-ABSORBING DRESSING
K864084 · FRO
Acme United Corp.
General & Plastic Surgery · 32d
Cleared Nov 21, 1986
FISHER PRICE SUNJAMMERS
K864399 · HQY
Fisher Price
Ophthalmic · 15d
Cleared Nov 20, 1986
OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE
K860858 · LYK
Olympus Corp.
Cardiovascular · 258d
Cleared Nov 20, 1986
CANDELA MODEL SPT-1, PULSED DYE LASER
K861179 · GEX
Candela Corp.
General & Plastic Surgery · 234d
Cleared Nov 20, 1986
CASE 12
K862316 · DSI
Marquette Electronics, Inc.
Cardiovascular · 155d
Cleared Nov 20, 1986
630C ELECTROCARDIOGRAPH
K863030 · DPS
Quinton, Inc.
Cardiovascular · 101d
Cleared Nov 20, 1986
TERUMO RADIFOCUS GUIDE WIRE
K863138 · DQX
Terumo Medical Corp.
Cardiovascular · 97d
Cleared Nov 20, 1986
CLAMPEASE FA
K863427 · DXC
Freund Medical Products
Cardiovascular · 77d
Cleared Nov 20, 1986
CHIN-FOGARTY INFLATION DEVICE
K863596 · DXT
American Edwards Laboratories
Cardiovascular · 66d
Cleared Nov 20, 1986
MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM
K863724 · DSI
Oxford Medilog, Inc.
Cardiovascular · 58d
Cleared Nov 20, 1986
EM III DISPOSABLE ELECTRODE
K863845 · DRX
Electromed Intl., Ltd.
Cardiovascular · 50d
Cleared Nov 20, 1986
MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD
K864002 · DTB
Intermedics, Inc.
Cardiovascular · 37d
Cleared Nov 20, 1986
MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
K864155 · DTJ
American Edwards Laboratories
Cardiovascular · 28d