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
152857–152880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1984
RIGHT ATRIAL CATHETER
K840742 · LJS
The Healthcare Group Laboratories, Inc.
General Hospital · 161d
Cleared Jul 13, 1984
SILVERTORQUE CEREBRAL CATHETER
K840762 · DQY
Surgimed Corp.
Cardiovascular · 141d
Cleared Jul 13, 1984
CONVENTIONAL PLASTIC DENTAL TRAYS
K841491 · EHY
Buffalo Dental Mfg. Co., Inc.
Dental · 94d
Cleared Jul 13, 1984
WEDGE PRESSURE CATHETER FLOW DIRECTED
K841705 · DYG
Mansfield Scientific, Inc.
Cardiovascular · 81d
Cleared Jul 13, 1984
CENTRAL VENOUS CATHETER W/BIG-GARD
K841828 · DQY
Norton Performance Plastics Corp.
Cardiovascular · 71d
Cleared Jul 13, 1984
KIDD VAGINAL SPECULUM
K841867 · HIB
Paul H. Schneider Ent.
Obstetrics & Gynecology · 70d
Cleared Jul 13, 1984
POLYURETHANE THERMAL DILUTION CATHET
K841876 · DYG
Waters Instruments, Inc.
Cardiovascular · 67d
Cleared Jul 13, 1984
SHEATH REMOVER
K841878 · LJS
Datascope Corp.
General Hospital · 67d
Cleared Jul 13, 1984
KERR SEALAPEX ROOT CANAL SEALER
K841910 · EJK
Sybron Corp.
Dental · 65d
Cleared Jul 13, 1984
ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232
K841922 · FRN
American Edwards Laboratories
General Hospital · 64d
Cleared Jul 13, 1984
PERCUTANEOUS CATHETER INTRODUCER SET
K842004 · DYB
Aries Medical, Inc.
Cardiovascular · 58d
Cleared Jul 13, 1984
AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT
K842113 · DRE
Mallinckrodt Critical Care
Cardiovascular · 116d
Cleared Jul 13, 1984
RAAF DUAL LUMEN CATHETER
K842176 · DQY
Quinton, Inc.
Cardiovascular · 35d
Cleared Jul 13, 1984
ADVANCED CARDIOVASCULAR-CORONARY GUID
K842195 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 39d
Cleared Jul 13, 1984
DISPOSABLE PILLOW
K842336 · KME
Monterey Mills, Inc.
General Hospital · 30d
Cleared Jul 13, 1984
ERIKA NEGATIVE PRESS. ARTERIAL BLOOD
K842436 · KOC
Erika, Inc.
Gastroenterology & Urology · 23d
Cleared Jul 13, 1984
PENTAD VOCALIZER
K842535 · ILQ
Pentad Corp.
Physical Medicine · 15d
Cleared Jul 12, 1984
GENERATED RETINAL REFLEX IMAGERY SYS
K840840 · HKM
Electro Optical Instruments
Ophthalmic · 139d
Cleared Jul 12, 1984
LAKEVILLE BODY VENTILATOR
K840885 · BYT
Edwards Ventilator Co.
Anesthesiology · 136d
Cleared Jul 12, 1984
HAEMATURIA CATHETERS
K841511 · KOD
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 92d
Cleared Jul 12, 1984
LIFESCAN EEG MONITOR
K841790 · OLT
Neurometrics
Neurology · 73d
Cleared Jul 12, 1984
NATURA-DENT VACUUM-FIRED PORCELAIN TEETH
K841826 · ELL
Parexel Intl. Corp.
Dental · 71d
Cleared Jul 12, 1984
JOHNSON & JOHNSON FLAVORED ETCHING GEL
K842078 · KLE
Johnson & Johnson Professionals, Inc.
Dental · 50d
Cleared Jul 12, 1984
BISFIL-I LIGHT CURABLE POSTERIOR COMPO
K842087 · EBF
Bisco, Inc.
Dental · 49d