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
160273–160296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1982
MEASELISA TEST KIT
K821762 · LJB
M.A. Bioproducts
Immunology · 45d
Cleared Jul 30, 1982
CENTURION ELECTRODE BELT
K821802 · DRX
Clinical Data, Inc.
Cardiovascular · 45d
Cleared Jul 30, 1982
UROGARD
K821829 · KNX
Buckman Consultants
Gastroenterology & Urology · 38d
Cleared Jul 30, 1982
PREGNANCY (W) EDGE
K821836 · QSB
Body Therapeutics, Inc.
Obstetrics & Gynecology · 38d
Cleared Jul 30, 1982
LDS MONITORING ELECTRODE
K821846 · DRX
Life Design Systems, Inc.
Cardiovascular · 38d
Cleared Jul 30, 1982
AUTOMATIC SINGLE CHANNEL ECG #399
K821888 · DPS
Birtcher Corp.
Cardiovascular · 35d
Cleared Jul 30, 1982
STAND, SURG. INSTRUMENT & DRESSING
K821921 · FSH
Emerson-Sack-Warner Corp.
General & Plastic Surgery · 31d
Cleared Jul 30, 1982
TABLE, SURG. INSTRUMENT & DRESSING
K821927
Emerson-Sack-Warner Corp.
General & Plastic Surgery · 31d
Cleared Jul 30, 1982
HAEM-C PLUS BLOOD REFERENCE CONTROLS
K821956 · JCN
Baker Instructions Corp.
Hematology · 30d
Cleared Jul 30, 1982
BBL PNEUMOSLIDE TEST
K821960 · GWC
Bd Becton Dickinson Vacutainer...
Microbiology · 29d
Cleared Jul 30, 1982
BBL STAPHYSLIDE TEST
K821962 · JWX
Bd Becton Dickinson Vacutainer...
Microbiology · 29d
Cleared Jul 30, 1982
LEONARD PERIPHERAL VENOUS PRESSURE CATH
K821996 · DYG
Norton Performance Plastics Corp.
Cardiovascular · 23d
Cleared Jul 30, 1982
RESPICORD
K821998 · BWF
Novamed Products, Inc.
Anesthesiology · 23d
Cleared Jul 30, 1982
BINOCULAR OPERATING MICROSCOPES &
K822009 · EPT
Kelleher Corp.
General & Plastic Surgery · 22d
Cleared Jul 30, 1982
BINOCULAR OPERATING MICROSCOPES &
K822012 · HBN
Kelleher Corp.
Neurology · 22d
Cleared Jul 30, 1982
BINOCULAR OPERATING MICROSCOPES AND
K822015 · FSO
Kelleher Corp.
General & Plastic Surgery · 22d
Cleared Jul 30, 1982
SERALYZER HEMOGLOBIN REAGENT STRIPS
K822044 · KHG
Miles Laboratories, Inc.
Hematology · 18d
Cleared Jul 30, 1982
SERALYZER HEMOGLOBIN TEST MODULE
K822045 · KHG
Miles Laboratories, Inc.
Hematology · 18d
Cleared Jul 30, 1982
SERALYZER HEMOGLOBIN CALIBRATORS
K822046 · KRZ
Miles Laboratories, Inc.
Hematology · 18d
Cleared Jul 30, 1982
D645-BACTERIOLOGICAL GAS LINE FILTER
K822097 · KRI
Electromedics, Inc.
Cardiovascular · 14d
Cleared Jul 30, 1982
SHOVEL RETRACTOR
K822109 · NBH
Bio-Blitz, Inc.
Orthopedic · 11d
Cleared Jul 30, 1982
SECA DIGITAL BABY SCALE 727
K822135 · FRW
Seca Corp.
General Hospital · 10d
Cleared Jul 30, 1982
DIGISTIM II
K822137 · BXN
Beuro Technology
Anesthesiology · 11d
Cleared Jul 30, 1982
NEUROSTIM II
K822138 · BXN
Neuro Technology
Anesthesiology · 11d