FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
166777–166800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 24, 1980
MEDI-THERM
K800812 · DWJ
Gaymar Industries, Inc.
Cardiovascular · 13d
Cleared Apr 24, 1980
DIAGNOSTIC PRODUCTS CORP. RIA CONTROL
K800813 · JJY
Diagnostic Products Corp.
Chemistry · 13d
Cleared Apr 24, 1980
CHLAMYDOSPORE AGAR
K800818 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 13d
Cleared Apr 24, 1980
AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY
K800820 · DBE
Calbiochem-Behring Corp.
Immunology · 13d
Cleared Apr 24, 1980
AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY
K800821 · DBM
Calbiochem-Behring Corp.
Immunology · 13d
Cleared Apr 24, 1980
KMA FLOW DIRECTED THERMODILUTION CATHETE
K800836 · KRB
Kma, Inc.
Cardiovascular · 9d