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
170473–170496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1979
SPECTROPHOTOMETER MODEL 650-40
K790236 · KHO
The Perkin-Elmer Corp.
Chemistry · 42d
Cleared Mar 15, 1979
ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI
K790252 · DHN
Meloy Laboratories, Inc.
Immunology · 37d
Cleared Mar 15, 1979
SYSTEMIC LUPUS
K790257 · DHC
Icl Scientific
Immunology · 37d
Cleared Mar 15, 1979
CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN
K790330 · JJY
Calbiochem-Behring Corp.
Immunology · 27d
Cleared Mar 15, 1979
RHEUMATELL
K790351 · DHR
Central Biological Co.
Immunology · 21d
Cleared Mar 15, 1979
TRYPTIC SOY AGAR W/ 5% HORSE BLOOD
K790375 · JSG
Granite Diagnostics, Inc.
Immunology · 20d
Cleared Mar 15, 1979
EMIT-QUINIDINE CONTROL
K790402 · LAS
Syva Co.
Toxicology · 17d
Cleared Mar 13, 1979
MONOJECT ARTERIAL BLOOD SAMPLING DEVICE
K790196 · CBT
Sherwood Medical Industries
Anesthesiology · 47d
Cleared Mar 12, 1979
LUPO-TEC
K782129 · DHC
Armkel, LLC
Immunology · 75d
Cleared Mar 12, 1979
RIA KIT, PROLACTIN
K790003 · CFT
Cis Radiopharmaceuticals, Inc.
Chemistry · 69d
Cleared Mar 12, 1979
ACA CREATINE KINASE ISOENZYMES
K790088 · JHS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 55d
Cleared Mar 12, 1979
URIC ACID, BOUND ENZYME
K790092 · KNK
Technicon Instruments Corp.
Chemistry · 55d
Cleared Mar 12, 1979
NEPHELOMETER, MIC-2000 LASER
K790103 · JQX
Dynatech Corp.
Chemistry · 55d
Cleared Mar 12, 1979
CHORIC-SHURE
K790138 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 49d
Cleared Mar 12, 1979
ONE-WAY VALVE
K790151 · CBP
Airlife, Inc.
Anesthesiology · 59d
Cleared Mar 12, 1979
REAGENT KIT, LANCER GLUCOSE
K790197 · JJF
Sherwood Medical Industries
Chemistry · 46d
Cleared Mar 12, 1979
PLASMA, STANDARDIZED NORMAL
K790204 · JPA
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 41d
Cleared Mar 09, 1979
OXYGENATOR, COBE CATALOG #42-220
K790356 · DTZ
Cobe Laboratories, Inc.
Cardiovascular · 15d
Cleared Mar 08, 1979
STIMULATOR, MODEL 1-600 ELECTRIC NERVR
K782164 · GZJ
Ipco Corp.
Neurology · 76d
Cleared Mar 08, 1979
C/N SCREEN
K790119 · JSI
Corning Medical & Scientific
Microbiology · 44d
Cleared Mar 08, 1979
PHYTOHAEMAGGLUTININ
K790239 · KIQ
Pharmacia Fine Chemicals
Pathology · 35d
Cleared Mar 08, 1979
IMAGER, PHO/SONIC SERIES 2000
K790285 · IYO
G.D. Searle and Co.
Radiology · 27d
Cleared Mar 07, 1979
MANIFOLD, UNIVERSAL I.P.P.B
K790152 · CAF
Airlife, Inc.
Anesthesiology · 54d
Cleared Mar 07, 1979
MANIFOLD, W/CORRUGATED TUBING
K790153 · CAF
Airlife, Inc.
Anesthesiology · 54d