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
146209–146232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1985
COULTER COUNTER MODEL T-660
K854114 · GKL
Coulter Electronics, Inc.
Hematology · 28d
Cleared Nov 05, 1985
DEMAND ETHYL ALCOHOL
K854130 · DIC
Cooper Biomedical, Inc.
Chemistry · 27d
Cleared Nov 05, 1985
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB
K854139 · KHG
Eastman Kodak Company
Hematology · 26d
Cleared Nov 05, 1985
TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN
K854152 · CDT
Technicon Instruments Corp.
Chemistry · 25d
Cleared Nov 05, 1985
SUR-FIT FACE MASK
K854161 · BSJ
Anesthesia Respiratory Technology, Inc.
Anesthesiology · 25d
Cleared Nov 05, 1985
TDX COCAINE METABOLITE
K854163 · DIO
Abbott Laboratories
Chemistry · 21d
Cleared Nov 05, 1985
TDX PHENCYCLIDINE
K854167 · LCM
Abbott Laboratories
Chemistry · 21d
Cleared Nov 05, 1985
ASA BLOOD TUBING LINES
K854271 · FJK
Organon Teknika Corp.
Gastroenterology & Urology · 13d
Cleared Nov 04, 1985
VERSABLADE
K852633 · HNN
Alphamedix, Inc.
Ophthalmic · 137d
Cleared Nov 04, 1985
VERSABLADE
K852706 · HNN
Alphamedix, Inc.
Ophthalmic · 131d
Cleared Nov 04, 1985
BEAVER R-K KNIFE
K852828 · HNN
Rudolph Beaver, Inc.
Ophthalmic · 125d
Cleared Nov 04, 1985
SMARTKNIFE SYSTEM
K853063 · HNN
CooperVision, Inc.
Ophthalmic · 108d
Cleared Nov 04, 1985
88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT
K853353 · KNT
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 84d
Cleared Nov 04, 1985
STORZ DIAMOND KNIFE
K853403 · HNN
Storz Instrument Co.
Ophthalmic · 84d
Cleared Nov 04, 1985
OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE
K853598 · HNN
Myocure, Inc.
Ophthalmic · 69d
Cleared Nov 04, 1985
ENDODYNAMIC SIEGEL SPHINCTEROTOME
K853680 · KNS
E-Z-Em, Inc.
Gastroenterology & Urology · 61d
Cleared Nov 04, 1985
UCD URINE SPECIMEN COLLECTOR
K854173 · KNX
Baker Instructions Corp.
Gastroenterology & Urology · 20d
Cleared Nov 01, 1985
TRAVENOL MULTIDAY INFUSOR 2C1080
K842905 · FRN
Travenol Laboratories, S.A.
General Hospital · 465d
Cleared Nov 01, 1985
ANTISERUM TO HUMAN PREALBUMIN
K850686 · JZJ
Kent Laboratories, Inc.
Immunology · 253d
Cleared Nov 01, 1985
ANTISERUM TO HUMAN APOLIPOPROTEIN B
K850690 · MSJ
Kent Laboratories, Inc.
Immunology · 253d
Cleared Nov 01, 1985
ANTISERUM TO HUMAN APOLIPOPROTEIN A-I
K850691 · MSJ
Kent Laboratories, Inc.
Immunology · 253d
Cleared Nov 01, 1985
PERCUTANEOUS GREENFIELD VENA CAVA FILTER SYSTEM
K852097 · DTK
Medi-Tech, Inc.
Cardiovascular · 170d
Cleared Nov 01, 1985
ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER
K852115 · FLF
Ars Enterprises, Inc.
General Hospital · 170d
Cleared Nov 01, 1985
DISPOSABLE STEAM BIOLOGICAL TEST PACK
K852192 · FRC
Parke-Davis Co.
General Hospital · 165d