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
167617–167640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1980
GEMENI IGG ASSAY
K800451 · DEW
Electro-Nucleonics Laboratories, Inc.
Immunology · 55d
Cleared Apr 24, 1980
GAMMA STICK GENTAMICIN RIA KIT
K800537 · DJB
Alpha Gamma Laboratory
Toxicology · 45d
Cleared Apr 24, 1980
GAMMA STICK CORTISOL RIA KIT/STICK KIT
K800538 · CGR
Alpha Gamma Laboratory
Chemistry · 45d
Cleared Apr 24, 1980
SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET
K800618 · DQO
Norton Performance Plastics Corp.
Cardiovascular · 37d
Cleared Apr 24, 1980
THERMODILUTION CATHETER INTRO. KIT
K800619 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 37d
Cleared Apr 24, 1980
VENOUS M/A INTERNAL JUGULAR KIT
K800620 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 37d
Cleared Apr 24, 1980
PERCUTANEOUS CATHETER INTRODUCER ADAPTER
K800621 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 37d
Cleared Apr 24, 1980
JACKSON ESOPHAGEAL BOUGIE, X-RAY OPAQUE
K800623 · KCD
Pilling Co.
Ear, Nose, Throat · 36d
Cleared Apr 24, 1980
URI-DIP (R)
K800626 · JXA
Pharma-Medica of Scandinavia, Ltd.
Microbiology · 36d
Cleared Apr 24, 1980
RAPI/TEX ASO STANDARD SERUM
K800642 · GTQ
Calbiochem-Behring Corp.
Microbiology · 31d
Cleared Apr 24, 1980
PRE-DENT SYSTEM
K800736 · KSS
Pre-Dent System
Hematology · 22d
Cleared Apr 24, 1980
RIONET &/OR RION HEARING AID MOD. HB-67S
K800738 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 24, 1980
RIONET &/OR RION HEARING AID MODEL HA-82
K800739 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 22d
Cleared Apr 24, 1980
STERILE WATER & SALINE IN PLASTIC BTL.
K800753 · BTT
Travenol Laboratories, S.A.
Anesthesiology · 20d
Cleared Apr 24, 1980
MISER INHALATION DEVICE, PART NO. 700
K800763 · CCQ
Vix Breathing Equipment Co.
Anesthesiology · 17d
Cleared Apr 24, 1980
CENTRIFICHEM CHOLESTEROL
K800765 · CHH
Union Carbide Corp.
Chemistry · 17d
Cleared Apr 24, 1980
ECHO-COMP
K800766 · DQK
Digisonics, Inc.
Cardiovascular · 17d
Cleared Apr 24, 1980
MOD. MCI 17 MANUAL CUFF INFLATOR
K800767 · DXQ
Medasonics, Inc.
Cardiovascular · 17d
Cleared Apr 24, 1980
Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST
K800769 · JQB
Sclavo, Inc.
Chemistry · 17d
Cleared Apr 24, 1980
DIGOCTK 125
K800773 · LCS
Sorin Biomedica, Fiat, USA, Inc.
Toxicology · 17d
Cleared Apr 24, 1980
SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS
K800780 · JPK
Sandare Chemical Co., Inc.
Hematology · 16d
Cleared Apr 24, 1980
GAS PAK II DIS. GENERATOR ENVELOPES
K800796 · KZJ
Bd Becton Dickinson Vacutainer...
Chemistry · 15d
Cleared Apr 24, 1980
HUMAN THYROID STIM. HORMONE/ARIA II
K800798 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 15d
Cleared Apr 24, 1980
CORN MEAL AGAR MEDIA
K800807 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 14d