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
152761–152784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1984
EEG BIOFEEDBACK DEVICE
K842022 · HCC
Electronics Research & Production
Neurology · 63d
Cleared Jul 20, 1984
TEMP. & GSR BIOFEEDBACK DEVICE
K842023 · HCC
Electronics Research & Production
Neurology · 63d
Cleared Jul 20, 1984
BENT WINGED MINI-VOL INFUSION SET
K842143 · FPA
Med Fusion Systems, Inc.
General Hospital · 51d
Cleared Jul 20, 1984
CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT
K842151 · LKH
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 51d
Cleared Jul 20, 1984
NEW JERSEY ACETABULAR COMPONENT &
K842202 · JDI
Endomedics, Inc.
Orthopedic · 46d
Cleared Jul 20, 1984
NEW JERSEY FEMORAL RESURFACING COMPONENT
K842233 · KXA
Endomedics, Inc.
Orthopedic · 45d
Cleared Jul 20, 1984
NEW JERSEY FEMORAL STEM
K842234 · KWL
Endomedics, Inc.
Orthopedic · 45d
Cleared Jul 20, 1984
CEFONICID 30 MCG SENSI-DISC
K842252 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 43d
Cleared Jul 20, 1984
VACUPULSE VACUUM UNIT
K842268 · IPF
I-Rep, Inc.
Physical Medicine · 42d
Cleared Jul 20, 1984
ELECTRODE, SURFACE EEG ELECTRODE
K842271 · GXY
Durden Enterprises, Inc.
Neurology · 42d
Cleared Jul 20, 1984
BECTEC NR-660 BACTERIAL DETECT SYS
K842279 · JTA
Bd Becton Dickinson Vacutainer...
Microbiology · 42d
Cleared Jul 20, 1984
GENERAL DIAG. CEFONICID 30MCG ANTIMIC
K842307 · JTN
General Diagnostics
Microbiology · 38d
Cleared Jul 20, 1984
CRITIKON TRIPLE-LUMEN CENTRAL VENOUS
K842316 · DQY
Critikon Company, LLC
Cardiovascular · 38d
Cleared Jul 20, 1984
SICKLE CELL REAGENT SET
K842368 · GHM
Livonia Diagnostics, Inc.
Hematology · 35d
Cleared Jul 20, 1984
LACTATE DEHYDROGENASE ASSAY KIT
K842507 · CFJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 20, 1984
CREATINE KINASE ASSAY KIT NAC
K842508 · CGS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 20, 1984
CALCIUM ASSAY KIT
K842509 · CIC
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 20, 1984
GLUCOSE ASSAY KIT-HEXOKINASE
K842510 · CFR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 20, 1984
CHESEBROUGH-POND'S REUSABLE URINARY LEG
K842553 · KNX
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 18d
Cleared Jul 20, 1984
GNC PLUS
K842587 · JTO
Vitek Systems, Inc.
Microbiology · 17d
Cleared Jul 20, 1984
EMERSON MOTION BED 6-MS & 6-ME
K842604 · IKZ
J. H. Emerson Co.
Physical Medicine · 15d
Cleared Jul 20, 1984
CA2000
K842611 · IKN
Nicolet Biomedical Instruments
Neurology · 15d
Cleared Jul 20, 1984
COMPACT AUDITORY
K842612 · IKN
Nicolet Biomedical Instruments
Neurology · 15d
Cleared Jul 20, 1984
COMPACT VISUAL
K842613 · IKN
Nicolet Biomedical Instruments
Neurology · 15d