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
174721–174744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 1977
PLATELET-CHEX-HUMAN
K770020 · JPK
Streck Laboratories, Inc.
Hematology · 41d
Cleared Feb 16, 1977
GAS CHROMOTOGRAPHS, SIGMA 1,2,3,4,&10
K770025 · KZQ
The Perkin-Elmer Corp.
Toxicology · 41d
Cleared Feb 16, 1977
COUNTER, BLOOD CELL & HEMATOCRIT
K770034 · GKL
Mallinckrodt Critical Care
Hematology · 37d
Cleared Feb 16, 1977
PACEGUARD
K770264 · DXH
Cardio Data
Cardiovascular · 5d
Cleared Feb 15, 1977
KARAYA GUM PRODUCTS - PROCESS CHANGE
K761319 · EZR
Howmedica Corp.
Gastroenterology & Urology · 50d
Cleared Feb 15, 1977
SUB. OF DIACETONE ACRYLAMIDE
K770180 · FPX
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 19d
Cleared Feb 14, 1977
URIN. L7-OH CORTICOSTEROID T(NON HYDRO)
K761271 · CDB
Eppendorf-Brinkmann, Inc.
Chemistry · 56d
Cleared Feb 14, 1977
AUTO CREATININE REAGENT (GILFORD 3400-E)
K761280 · CGX
Harleco
Chemistry · 56d
Cleared Feb 14, 1977
I.V. PUMP, ABBOTT/SHAW LIFECARE
K770087 · FRN
Abbott Laboratories
General Hospital · 28d
Cleared Feb 14, 1977
GAMMA 4000 SCINTILLATION COUNTER
K770088 · JJJ
Beckman Instruments, Inc.
Immunology · 28d
Cleared Feb 14, 1977
DISPOSABLE BACTERIA FILTER
K770136 · CAH
Omnicon Medical Corp.
General Hospital · 21d
Cleared Feb 14, 1977
NASO-LACRIMAL DUCT INSERT
K770194 · HNL
Concept, Inc.
Ophthalmic · 14d
Cleared Feb 14, 1977
ANALYTIX AUTO SAMPLE PREP. STA. 1600
K770210 · JQW
G.D. Searle and Co.
Immunology · 14d
Cleared Feb 14, 1977
BLOOD/FLUID WARMER MODEL DW-1000A
K770232 · BSB
Gorman Rupp Industries
Hematology · 7d
Cleared Feb 14, 1977
MODEL 880 REHABILITATION TRAINER
K770234 · ISD
Quinton, Inc.
Physical Medicine · 7d
Cleared Feb 14, 1977
DIGITAL HEART RATE METER
K770239 · DRT
Burdick Corp.
Cardiovascular · 7d
Cleared Feb 14, 1977
TREADMILL STRESS EXERCISE SYSTEM
K770240 · IOL
Burdick Corp.
Physical Medicine · 7d
Cleared Feb 14, 1977
NEONATAL T4 RIA KIT
K770241 · CDX
Diagnostic Products Corp.
Immunology · 7d
Cleared Feb 14, 1977
ELGILOY STYLET
K770243 · DRR
Cardiac Pacemakers, Inc.
Cardiovascular · 7d
Cleared Feb 14, 1977
ABDOMINAL FETAL ECG MODULE
K770245 · KXN
Mennen Greatbatch Electonics
Obstetrics & Gynecology · 7d
Cleared Feb 14, 1977
ISOLATED EEG AMPLIFIER MODULE
K770246 · GWQ
Mennen Greatbatch Electonics
Neurology · 7d
Cleared Feb 14, 1977
D.C. AMPLIFIER MODULE
K770247 · DRQ
Mennen Greatbatch Electonics
Cardiovascular · 7d
Cleared Feb 14, 1977
VENTILATOR SET - CODE 2C7109
K770249 · BTT
Travenol Laboratories, S.A.
Anesthesiology · 6d
Cleared Feb 11, 1977
REFLOMAT/REFLOTEST SYSTEM
K761148 · CGA
Boehringer Mannheim Corp.
Chemistry · 77d