FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
133537–133560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1988
T.E.N.S. UNIT SIGMA & TX-3
K883188 · GZJ
Diamond Medical Equipment, Inc.
Neurology · 141d
Cleared Dec 16, 1988
HDL-CHOLESTEROL PRECIPITATING REAGENT
K883543 · CHH
Medical Analysis Systems, Inc.
Chemistry · 119d
Cleared Dec 16, 1988
NEUROWAVE SYSTEM 2
K883557 · GWQ
Durden Enterprises, Inc.
Neurology · 119d
Cleared Dec 16, 1988
MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS
K883606 · LKD
Hewlett-Packard Co.
Anesthesiology · 115d
Cleared Dec 16, 1988
LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73
K883615 · DJY
Supelco, Inc.
Toxicology · 114d
Cleared Dec 16, 1988
NAPARIMA BIORESISTANCE METER & BODY COMP. ANALYZER
K883919 · DSB
Naparima, Inc.
Cardiovascular · 91d
Cleared Dec 16, 1988
DSM-1 DOSIMETER
K884051 · CAF
S & M Instrument Co.
Anesthesiology · 81d
Cleared Dec 16, 1988
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM
K884063 · CCE
C.R. Bard, Inc.
Anesthesiology · 81d
Cleared Dec 16, 1988
THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101
K884098 · BYI
American Biosystems, Inc.
Anesthesiology · 79d
Cleared Dec 16, 1988
OXINET N-7500 PULSE OXIMETRY NETWORK
K884142 · DXH
Nellcor, Inc.
Cardiovascular · 77d
Cleared Dec 16, 1988
SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER
K884329 · DQA
Baxter Healthcare Corp
Anesthesiology · 63d
Cleared Dec 16, 1988
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE)
K884355 · JIY
Eastman Kodak Company
Chemistry · 60d
Cleared Dec 16, 1988
PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT
K884525 · BZO
Intertech/Ohio
Anesthesiology · 50d
Cleared Dec 16, 1988
PHOSPHORUS TEST (PHOS) ITEM #65666
K884735 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared Dec 16, 1988
TDX METHADONE ASSAY
K884968 · DJR
Abbott Laboratories
Toxicology · 16d
Cleared Dec 16, 1988
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
K885006 · LJC
Abbott Laboratories
Microbiology · 14d
Cleared Dec 15, 1988
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST
K882440 · LLM
Zeus Scientific, Inc.
Microbiology · 184d
Cleared Dec 15, 1988
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES
K882447 · LSE
Zeus Scientific, Inc.
Microbiology · 184d
Cleared Dec 15, 1988
BIODOP(TM)
K883334 · HEK
Diagnosis Related Systems, Inc.
Obstetrics & Gynecology · 128d
Cleared Dec 15, 1988
ABC FP ANALYZER
K883533 · JJE
Intl. Bioclinical, Inc.
Chemistry · 119d
Cleared Dec 15, 1988
THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL
K883726 · JLW
Immuchem Corp.
Chemistry · 106d
Cleared Dec 15, 1988
UROIMAGER
K883925 · IYO
Ausonics Pty , Ltd.
Radiology · 90d
Cleared Dec 15, 1988
CENTURY COLOR TRACE
K884152 · DSI
Biomedical Systems, Inc.
Cardiovascular · 73d
Cleared Dec 15, 1988
TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS
K884224 · CIG
A-Kem, Inc.
Chemistry · 70d