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
169633–169656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1979
VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT
K791355 · DPO
Ventrex Laboratories, Inc.
Toxicology · 20d
Cleared Aug 10, 1979
CAM-10 CHEST SHELL
K791406 · BYT
Lifecare Services, Inc.
Anesthesiology · 10d
Cleared Aug 10, 1979
MAINSTREAM ELEVATING WHEEL CHAIR
K791408 · ITI
Summit Services, Inc.
Physical Medicine · 15d
Cleared Aug 10, 1979
TOILET TRAINER FOR HANDICAPPED CHILD
K791423 · ILS
Kaye Products, Inc.
Physical Medicine · 10d
Cleared Aug 07, 1979
HEMODIALYZERS RP-510 AND RP-514
K791448 · FJG
Hospal Medical Corp.
Gastroenterology & Urology · 1d
Cleared Aug 03, 1979
NON-RETENTION ENEMA SYSTEM
K781923 · KPL
Hudson Kendale Assoc., Inc.
Gastroenterology & Urology · 260d
Cleared Aug 03, 1979
ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN
K790710 · DDY
Kent Laboratories, Inc.
Immunology · 113d
Cleared Aug 03, 1979
ANTISERUM TO HUMAN C-REACTIVE PROTEINS
K790716 · DCN
Kent Laboratories, Inc.
Immunology · 113d
Cleared Aug 03, 1979
LODA WRIST PROSTHESIS
K790774 · KWM
Depuy, Inc.
Orthopedic · 105d
Cleared Aug 03, 1979
PORCELIT
K790806 · EBA
Harry J. Bosworth Co.
Dental · 101d
Cleared Aug 03, 1979
METALIT
K790807 · EBA
Harry J. Bosworth Co.
Dental · 101d
Cleared Aug 03, 1979
SUBCUTANEOUS TISSUE EXPANDER
K790842 · LCJ
Heyer Schulte Corp.
General & Plastic Surgery · 93d
Cleared Aug 03, 1979
SURGICAL DRAPE CLIP #201
K790855 · GDO
C. Intl.
General & Plastic Surgery · 91d
Cleared Aug 03, 1979
SCREENING AUDIOMETER, HIGH FREQUENCY
K790878 · EWO
Vicon Instrument Co.
Ear, Nose, Throat · 88d
Cleared Aug 03, 1979
OPHTHALMIC DRESSING TRAY
K790909 · HOX
Pent-Cal, Inc.
Ophthalmic · 81d
Cleared Aug 03, 1979
INTRACRANIAL PRESSURE MONITORING
K790920 · GWM
Codman & Shurtleff, Inc.
Neurology · 86d
Cleared Aug 03, 1979
DELTON* PIT AND FISSURE SEALENT
K790935 · EBC
Johnson & Johnson Professionals, Inc.
Dental · 79d
Cleared Aug 03, 1979
S/A 7800 BIRTH SUPPORT CHAIR
K790950 · KNC
Schlosser Alberti Co.
Obstetrics & Gynecology · 74d
Cleared Aug 03, 1979
SA/7860 FETAL HEART MONITOR (DOPPLER)
K790951 · KNG
Schlosser Alberti Co.
Obstetrics & Gynecology · 74d
Cleared Aug 03, 1979
STAT DIFF STAIN
K791007 · KQC
Bioscientific
Hematology · 64d
Cleared Aug 03, 1979
ECA (SPECIAL) HEME BUFFER
K791008 · JBD
Electrophoresis Corp. of America
Hematology · 64d
Cleared Aug 03, 1979
MCSPADDEN CONDENSOR
K791019 · EKR
Techdent, Inc.
Dental · 63d
Cleared Aug 03, 1979
ENDOSCOPIC INSTRUMENT
K791052 · HET
Eder Instrument Co, Inc.
Obstetrics & Gynecology · 58d
Cleared Aug 03, 1979
H-H SLOTTED CATHETER-RESERVOIR
K791075 · JXG
Holter-Hausner Intl.
Neurology · 52d