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
142081–142104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1986
AVTECH LWP*(LOW POROSITY) MWP*(MEDIUM POROSITY)
K862697 · DSY
Advanced Vascular Technologies, Inc.
Cardiovascular · 143d
Cleared Dec 05, 1986
ULTRA SOFTWARE MODULE: MODEL 2016
K863046 · KRG
Cardiac Pacemakers, Inc.
Cardiovascular · 115d
Cleared Dec 05, 1986
EPICARDIA, PC/FD
K863643 · DSI
Medicomp, Inc.
Cardiovascular · 78d
Cleared Dec 05, 1986
DURACATH, GISH MODEL NO. DVAC-XXXX
K863792 · BSO
Gish Biomedical, Inc.
Anesthesiology · 70d
Cleared Dec 05, 1986
TUBULICID BLUE LABEL
K864050 · LBH
Dental Dimensions Supply Co.
Dental · 50d
Cleared Dec 05, 1986
TUBULITEC PRIMER
K864052 · LBH
Dental Dimensions Supply Co.
Dental · 50d
Cleared Dec 05, 1986
TUBULITEC LINER
K864053 · EJK
Dental Dimensions Supply Co.
Dental · 50d
Cleared Dec 05, 1986
TELECTRONICS SREW-IN/SLIM LINE PACING LEADS
K864098 · DTB
Daig Corp.
Cardiovascular · 45d
Cleared Dec 05, 1986
AQUAVALVE
K864147 · BYH
Respiratory Care, Inc.
Anesthesiology · 44d
Cleared Dec 05, 1986
EMERSON 3MV VOLUME VENTILATOR
K864394
J. H. Emerson Co.
Anesthesiology · 29d
Cleared Dec 05, 1986
MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER
K864428 · DTB
Intermedics, Inc.
Cardiovascular · 23d
Cleared Dec 05, 1986
MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD
K864564 · DTB
Intermedics, Inc.
Cardiovascular · 16d
Cleared Dec 05, 1986
ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH
K864585 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 18d
Cleared Dec 04, 1986
DIGITAL PULSE METER HRM-100E & ETC.
K850449 · DRT
Sanyo Electric, Inc.
Cardiovascular · 667d
Cleared Dec 04, 1986
MED-PEN/MED-POINT
K853733 · CGA
Garid, Inc.
Chemistry · 454d
Cleared Dec 04, 1986
INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT
K861725 · FOZ
Parke-Davis Co.
General Hospital · 212d
Cleared Dec 04, 1986
3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)
K861985 · MVR
3M Company
General & Plastic Surgery · 196d
Cleared Dec 04, 1986
URINE DIAGNOSTIC REAGENT STRIPS
K862806 · JJB
Amatech International, Inc.
Chemistry · 134d
Cleared Dec 04, 1986
TRANSFERMETER
K863066 · JQF
J. D. Assoc.
Chemistry · 114d
Cleared Dec 04, 1986
SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG
K863086 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 114d
Cleared Dec 04, 1986
TERUMO SENSIBEAD EIA FSH KIT
K863928 · CGJ
Terumo Medical Corp.
Chemistry · 57d
Cleared Dec 04, 1986
U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST
K863980 · CJE
U. S. Diagnostics, Inc.
Chemistry · 51d
Cleared Dec 04, 1986
SUPERCATH I.V. CATHETER
K864038 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 49d
Cleared Dec 04, 1986
U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST
K864081 · CHH
U. S. Diagnostics, Inc.
Chemistry · 45d