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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
151273–151296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1984
STREP ID TRIPLATE
K844019 · JTO
Remel Co.
Microbiology · 16d
Cleared Oct 30, 1984
IMPEDANCE/8200 MONITOR-MODEL 8300
K840358 · KRC
Aequitron Medical, Inc.
Cardiovascular · 278d
Cleared Oct 30, 1984
MUSE-DP
K840932 · DXN
Marquette Electronics, Inc.
Cardiovascular · 242d
Cleared Oct 30, 1984
SCOTT SELECTICULT-HSV ISOLATION &
K841680 · GQL
Scott Laboratories, Inc.
Microbiology · 190d
Cleared Oct 30, 1984
ANTI-SCHISTOSOMA SPECIES KIT
K842660 · GNH
Amico Lab, Inc.
Immunology · 112d
Cleared Oct 30, 1984
EMA LIV CENERA DENTAL CEMENT
K842995 · EMA
Int'L Corp.
Dental · 92d
Cleared Oct 30, 1984
SERVO MED NYSTAGMOGRAPH NG-1
K843004 · GWN
Servo Med, Inc.
Neurology · 92d
Cleared Oct 30, 1984
ORAL THC-CANNABINOIDS DIRECT RIA KIT
K843534 · LAT
Immunalysis Corporation
Toxicology · 53d
Cleared Oct 30, 1984
DETECT-A-STREP
K843590 · GTZ
Antibodies, Inc.
Microbiology · 48d
Cleared Oct 30, 1984
RETIC-SET
K843619 · KQC
R&D Systems, Inc.
Hematology · 46d
Cleared Oct 30, 1984
PHOTOMETER 90IYS
K843668 · JJQ
Institute Virion , Ltd.
Microbiology · 43d
Cleared Oct 30, 1984
SIGMA PERIODIC ACID-SCHIFF STAIN 395
K843752 · HZT
Sigma Chemical Co.
Hematology · 35d
Cleared Oct 30, 1984
BETA QUIK V
K843795 · JHI
Pacific Biotech, Inc.
Chemistry · 33d
Cleared Oct 30, 1984
HUMAN SERUM ANTICONVULSANT DRUG CONTROL
K843818 · DIF
Quantimetrix Corp.
Toxicology · 32d
Cleared Oct 30, 1984
PARATHYROID HORMONE MID-MOLECULE RIA-KIT
K843870 · CEW
Diagnostic Products Corp.
Chemistry · 28d
Cleared Oct 30, 1984
PARATHYROID HORMONE C-TERMINAL RIA KIT
K843871 · CEW
Diagnostic Products Corp.
Chemistry · 28d
Cleared Oct 30, 1984
MAGNESIUM REAGENT SET
K843893 · JGJ
Livonia Diagnostics, Inc.
Chemistry · 27d
Cleared Oct 30, 1984
TOTAL CALCIUM REAGENT SET
K843895 · CIC
Livonia Diagnostics, Inc.
Chemistry · 27d
Cleared Oct 30, 1984
COBAS FP TDM CONTROLS
K843913 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Oct 30, 1984
TDX REA CREATININE
K843916 · CGX
Abbott Laboratories
Chemistry · 25d
Cleared Oct 30, 1984
SPOTTEST LOEFFLER METHYLENE BLUE STAIN
K843919 · KFC
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Oct 30, 1984
IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I
K843930 · CGJ
Euro-Diagnostics BV
Immunology · 25d
Cleared Oct 30, 1984
LINEAR ENZYMATIC URIC ACID SYSTEM
K843938 · KNK
Simmler, Inc.
Chemistry · 21d
Cleared Oct 30, 1984
PYR BROTH
K843987 · JTO
Remel Co.
Microbiology · 19d