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
100993–101016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 1995
DILATATION CATHETER, BALLOON
K953004 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 77d
Cleared Sep 13, 1995
PRIME CEMENTED SMALL FEMORAL STEM
K953033 · JDI
Orthopaedic Innovations, Inc.
Orthopedic · 75d
Cleared Sep 13, 1995
LOW PROFILE TITANIUM MODEL CATALOG #1003
K953110 · LJT
Therex Corp.
General Hospital · 72d
Cleared Sep 13, 1995
KIS-- FOUR HOLE CYLINDER
K953139 · DZE
Implant Center of the Palm Beaches
Dental · 69d
Cleared Sep 13, 1995
SCREW IMPLANTS, GRADE 3
K953235 · DZE
The Implant Center of the Palm Beaches
Dental · 64d
Cleared Sep 13, 1995
CYLINDER IMPLANTS HA, TP, GRADE 3
K953236 · DZE
The Implant Center of the Palm Beaches
Dental · 64d
Cleared Sep 13, 1995
CONVEEN LEG BAG STRAP
K953783 · FAQ
Coloplast Corp.
Gastroenterology & Urology · 30d
Cleared Sep 12, 1995
POLIOVIRUS 3 MONOCLONAL ANTIBODY
K940017 · GOE
Light Diagnostics
Microbiology · 616d
Cleared Sep 12, 1995
POLIOVIRUS BLEND MONOCLONAL ANTIBODIES
K940026 · GOE
Light Diagnostics
Microbiology · 617d
Cleared Sep 12, 1995
ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES
K940027 · GOE
Chemicon Intl., Inc.
Microbiology · 617d
Cleared Sep 12, 1995
POLIOVIRUS 2 MONOCLONAL ANTIBODY
K940034 · GOE
Light Diagnostics
Microbiology · 616d
Cleared Sep 12, 1995
ENTEROVIRUS 71 MONOCLONAL ANTIBODY
K940473 · GOE
Chemicon Intl., Inc.
Microbiology · 587d
Cleared Sep 12, 1995
MASTER-NEB NEBULIZER COMPRESSOR SYSTEM
K943717 · CAF
Howard K. Mann & Assoc.
Anesthesiology · 407d
Cleared Sep 12, 1995
OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES
K945265 · HIH
Optus, Inc.
Obstetrics & Gynecology · 319d
Cleared Sep 12, 1995
INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS
K945498 · FGE
Instent, Inc.
Gastroenterology & Urology · 308d
Cleared Sep 12, 1995
DATACELL 18MS
K945678 · GKZ
Danam Electronics
Hematology · 298d
Cleared Sep 12, 1995
CADWELL EASY AMBULATORY EEG
K946094 · GWQ
Cadwell Laboratories, Inc.
Neurology · 272d
Cleared Sep 12, 1995
HEARING AID (ALL-IN-THE-EAR)
K951712 · ESD
Omega Hearing Aid Center
Ear, Nose, Throat · 152d
Cleared Sep 12, 1995
MEDELA'S FOOT PUMP
K952034 · HGY
Medela, Inc.
Obstetrics & Gynecology · 134d
Cleared Sep 12, 1995
SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
K952438 · HQY
Taiwan Eva Industrial Co., Inc.
Ophthalmic · 110d
Cleared Sep 12, 1995
VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI,...
K952597 · HQZ
Point of View Optical Outlet, Inc.
Ophthalmic · 98d
Cleared Sep 12, 1995
TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM
K952697 · HWC
Smith & Nephew Richards, Inc.
Orthopedic · 91d
Cleared Sep 12, 1995
LIGHT-CURE PC
K952856 · DYH
Midwest Orthodontic Mfg.
Dental · 82d
Cleared Sep 12, 1995
BAIR HUGGER MODEL 655 BLANKET
K952864 · DWJ
Augustine Medical, Inc.
Cardiovascular · 82d