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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
94153–94176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1997
T1 CONTROL HIGH SPEED DENTAL HANDPIECE
K965238 · EFA
Siemens AG
Dental · 78d
Cleared Mar 19, 1997
ASCEND BALLOON DAILATION CATHETER
K970041 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 72d
Cleared Mar 19, 1997
COMEG ENDOSCOPY GRASPING FORCEPS
K970489 · FFL
Comeg Endoscopy
Gastroenterology & Urology · 37d
Cleared Mar 19, 1997
PROMED 55-G SOFT DAILY WEAR CONTACT LENS
K970615 · LPL
Biomed Devices Corp.
Ophthalmic · 29d
Cleared Mar 18, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT
K962408 · CEC
Nichols Institute Diagnostics
Chemistry · 270d
Cleared Mar 18, 1997
MOSS MIAMI SPINAL SYSTEM
K962628 · KWP
Depuy, Inc.
Orthopedic · 256d
Cleared Mar 18, 1997
GENESIS RMP
K963268 · JRA
Tecan U.S., Inc.
Chemistry · 210d
Cleared Mar 18, 1997
KENDALL DUAL LUMEN CATHETER
K963446 · MPB
Kendall Healthcare Products Co....
Gastroenterology & Urology · 196d
Cleared Mar 18, 1997
ILT ARGON HP
K964524 · EBZ
Ion Laser Technology
Dental · 126d
Cleared Mar 18, 1997
AMSINO URINARY DRAINAGE BAG
K964745 · KNX
Amsino Intl., Inc.
Gastroenterology & Urology · 112d
Cleared Mar 18, 1997
RSV ANTIGEN CONTROL SLIDES
K964870 · GQG
Viral Antigens, Inc.
Microbiology · 103d
Cleared Mar 18, 1997
VZV ANTIGEN CONTROL SLIDES
K964872 · GQW
Viral Antigens, Inc.
Microbiology · 103d
Cleared Mar 18, 1997
CMV ANTIGEN CONTROL SLIDES
K964875 · GQH
Viral Antigens, Inc.
Microbiology · 103d
Cleared Mar 18, 1997
ELECSYS TESTOSTERONE ASSAY
K964889 · CDZ
Boehringer Mannheim Corp.
Chemistry · 102d
Cleared Mar 18, 1997
THROMBONOSTIKA F1.2
K964934 · MIF
Organon Teknika Corp.
Hematology · 99d
Cleared Mar 18, 1997
SYSMEX CA-1000/SYSMEX CA-5000
K964946 · JPA
Sysmex Corp.
Hematology · 98d
Cleared Mar 18, 1997
MDA HEPARIN ANTI-X ASSAY
K965076 · KFF
Organon Teknika Corp.
Hematology · 89d
Cleared Mar 18, 1997
COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)
K965087 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 89d
Cleared Mar 18, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4...
K965142 · CEC
Johnson & Johnson Clinical...
Chemistry · 85d
Cleared Mar 18, 1997
MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM
K965251 · MAJ
Medtronic Vascular
General Hospital · 89d
Cleared Mar 18, 1997
NIDEK CYBERSCAN
K970017 · GEX
Nidek, Inc.
General & Plastic Surgery · 75d
Cleared Mar 18, 1997
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K970151 · HET
Smith & Nephew, Inc.
Obstetrics & Gynecology · 62d
Cleared Mar 18, 1997
RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK...
K970279 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 54d
Cleared Mar 18, 1997
COMBIPROT EMERGENCY ENFUSION DEVICE
K970359 · LHI
B.Braun Medical, Inc.
General Hospital · 46d