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
162097–162120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 1982
TELETRED GAIT ANALYSIS SYSTEM
K813486 · IOL
Structural Analysis Systems, Inc.
Physical Medicine · 59d
Cleared Jan 29, 1982
FARRORS TMJ CASSETTE HOLDER
K813506 · KXF
Brell Mar Products, Inc.
General Hospital · 45d
Cleared Jan 29, 1982
LIQUIZYME CREATININE REAGENT SET
K813560 · CGX
Amresco, Inc.
Chemistry · 38d
Cleared Jan 29, 1982
SPECTRUM PEDIATRIC CARDLE TABLE
K813561 · KXH
Spectrum X-Ray Corp.
Radiology · 38d
Cleared Jan 29, 1982
ESTILUX POSTERIOR XR
K813568 · EBF
Kulzer, Inc.
Dental · 38d
Cleared Jan 29, 1982
PRESSURE INDICATOR-REGULATOR
K813577 · DQO
Advanced Catheter Systems
Cardiovascular · 37d
Cleared Jan 29, 1982
DIALYSIS CONCENTRATE
K813586 · KPO
Diversified Medical Services
Gastroenterology & Urology · 32d
Cleared Jan 29, 1982
HOLTER PERFORMER
K813602 · DSH
Applied Cardiac Systems
Cardiovascular · 32d
Cleared Jan 29, 1982
CORONARY INFUSION KIT
K820001 · DQO
Mallinckrodt Critical Care
Cardiovascular · 25d
Cleared Jan 29, 1982
NEISSERIA GONORRHOEAE TEST
K820007 · LIC
New Horizons Diagnostics Co.
Microbiology · 25d
Cleared Jan 29, 1982
PIPERACILLIN 100MCG. ANTIMICROBIAL
K820019 · JTN
General Diagnostics
Microbiology · 24d
Cleared Jan 29, 1982
CARDIOVASCULAR DEVICES
K820045 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 22d
Cleared Jan 29, 1982
ANESTHESIOLOGY DEVICES
K820046 · DRS
Bentley Laboratories, Inc.
Cardiovascular · 22d
Cleared Jan 29, 1982
OBUS FORME ORTHOPEDIC BRACE, UPRIGHT
K820051 · IQE
Obus Forme, Ltd.
Physical Medicine · 21d
Cleared Jan 29, 1982
ELASTIC BANDAGE
K820094 · FQM
Stan-Pak Ent.
General Hospital · 16d
Cleared Jan 29, 1982
SUBCLAVIAN JUGULAR CATHETER SET
K820102 · DQR
Luther Medical Products, Inc.
Cardiovascular · 14d
Cleared Jan 29, 1982
RADIATION STERILIZED SUCTION CATHETERS
K820109 · BSY
Travenol Laboratories, S.A.
Anesthesiology · 14d
Cleared Jan 29, 1982
PATIENT GUIDED KNEE EXERCISER
K820120 · BXB
Richard'S Medical Equip., Inc.
Physical Medicine · 11d
Cleared Jan 29, 1982
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN CNTRL
K820129 · LAS
Syva Co.
Toxicology · 11d
Cleared Jan 29, 1982
URINARY DRAINAGE BAG
K820136 · KNX
Megaplast, Inc.
Gastroenterology & Urology · 11d
Cleared Jan 29, 1982
K-AID
K820150 · KPO
Sytek Laboratories
Gastroenterology & Urology · 10d
Cleared Jan 29, 1982
KEY MED LEEDS ENDOSCOPE DISINFECTOR
K820152 · FEB
Keymed, Inc.
General Hospital · 10d
Cleared Jan 29, 1982
O.N.A.T.
K820175 · KNC
Latex Medical Devices, Inc.
Obstetrics & Gynecology · 8d
Cleared Jan 29, 1982
BIO-DERM COUPLING LOTION
K827885 · HGL
Whs Products, Inc.
Radiology · 28d