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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
158929–158952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 1982
VERTEX MONITORING CATHETER
K823253 · DXT
Vertex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
REUSABLE METAL STOPCOCK
K823254 · DXT
Vertex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE
K823256 · DXT
Vertex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
VENOUS RESERVOIR BAG #BMR-1400
K823272 · DTN
Bentley Laboratories, Inc.
Cardiovascular · 58d
Cleared Dec 30, 1982
MODELS DPT 1000/DPT 1000NS
K823286 · DRS
Bio-Med Corp.
Cardiovascular · 56d
Cleared Dec 30, 1982
NEUROMEDICS PACETRON HEART RATE MONITOR
K823290 · DRT
Intermedics, Inc.
Cardiovascular · 55d
Cleared Dec 30, 1982
CLEAR VINYL MONITORING CONNECTOR
K823340 · DXT
Vertex Medical Corp.
Cardiovascular · 52d
Cleared Dec 30, 1982
BENZING RETROGRADE ADMIN. SET
K823373 · FMG
Beech Medical, Inc.
General Hospital · 48d
Cleared Dec 30, 1982
HOLTER KIT MODEL #5000 SERIES
K823414 · DSH
Andover Medical, Inc.
Cardiovascular · 45d
Cleared Dec 30, 1982
MON-A-THERM MYOCARDIAL TEMP. SENSOR
K823435 · KRB
Burditt & Calkins-Siemens-Elema
Cardiovascular · 44d
Cleared Dec 30, 1982
OXYGENATORS #BOS-10, 105, 5S
K823456 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 42d
Cleared Dec 30, 1982
TERUFUSION THREE-WAY STOPCOCK
K823469 · FMG
Terumo Medical Corp.
General Hospital · 38d
Cleared Dec 30, 1982
ENZYMATIC GLUCOSE DETERMINATION
K823474 · CGA
The Dow Chemical Co.
Chemistry · 38d
Cleared Dec 30, 1982
ELECTROCARDIOGRAPH #334
K823488 · DPS
Birtcher Corp.
Cardiovascular · 37d
Cleared Dec 30, 1982
CHOLESTEROL REAGENT
K823500 · CHH
Ac Biochemical Laboratories, Inc.
Toxicology · 36d
Cleared Dec 30, 1982
ESA CAMERA
K823516 · FWH
Concept, Inc.
General & Plastic Surgery · 31d
Cleared Dec 30, 1982
JACKET & SET
K823533 · DTR
Shiley, Inc.
Cardiovascular · 31d
Cleared Dec 30, 1982
IMMUNOGLOBULIN CONTROL
K823566 · CZP
Syva Co.
Chemistry · 27d
Cleared Dec 30, 1982
IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM
K823567 · CZP
Syva Co.
Immunology · 27d
Cleared Dec 30, 1982
MYOTEST NERVE STIMULATOR
K823583 · BXN
Prothia USA, Inc.
Anesthesiology · 24d
Cleared Dec 30, 1982
FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO-
K823584 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 24d
Cleared Dec 30, 1982
PICTURES & WORD IDENTIFICATION CVA PAT
K823608 · ILP
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Dec 30, 1982
ADJ. WOODEN BOARD FOR WRITING
K823612 · ILP
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Dec 30, 1982
INSULATED THERMOELASTOMER MITT
K823622 · IMA
Fred Sammons, Inc.
Physical Medicine · 24d