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
77521–77544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2001
DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
K011944 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 90d
Cleared Sep 19, 2001
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
K011954 · HSX
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Sep 19, 2001
HORIZON OUTLOOK WITH DOSECOM
K011975 · FRN
B.Braun Medical, Inc.
General Hospital · 86d
Cleared Sep 19, 2001
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
K011996 · HIL
Procter & Gamble Co.
Obstetrics & Gynecology · 84d
Cleared Sep 19, 2001
RHS HELMET
K012007 · MVA
Restorative Health Svs, Inc.
Neurology · 84d
Cleared Sep 19, 2001
3I CALCIUM SULFATE BONE CEMENT
K012047 · LYC
Implant Innovations, Inc.
Dental · 82d
Cleared Sep 19, 2001
GEODESIC EEG SYSTEM, MODEL 200
K012079 · GWQ
Electrical Geodesics, Incorporated
Neurology · 78d
Cleared Sep 19, 2001
MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP
K012124 · GAP
Johnson & Johnson Medical (China) , Ltd.
General & Plastic Surgery · 75d
Cleared Sep 19, 2001
LOWSLEY SUPRAPUBIC TRACTOR
K012153 · KOB
Circon Video
Gastroenterology & Urology · 70d
Cleared Sep 19, 2001
AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K012154 · LNH
Aurora Imaging Technology, Inc.
Radiology · 70d
Cleared Sep 19, 2001
OLDELFT THORASCAN MODEL NUMBER 180T
K012165 · KPR
Nucletron Corp.
Radiology · 70d
Cleared Sep 19, 2001
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
K012201 · GAT
Aesculap, Inc.
General & Plastic Surgery · 68d
Cleared Sep 19, 2001
WIENER LAB. UREA UV CINETICA AA
K012260 · CDQ
Wiener Laboratories Saic
Chemistry · 63d
Cleared Sep 19, 2001
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · KXT
Diagnostic Products Corp.
Toxicology · 61d
Cleared Sep 19, 2001
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
K012334 · MAI
Bionx Implants, Inc.
Orthopedic · 57d
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012371 · DDG
Roche Diagnostics Corp.
Immunology · 55d
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012393 · DDG
Roche Diagnostics Corp.
Immunology · 54d
Cleared Sep 19, 2001
BIFURCATED VACCINATING NEEDLE
K012515 · SCL
Precision Medical Products, Inc.
General Hospital · 44d
Cleared Sep 19, 2001
M71 POWER WHEELCHAIR
K012927 · ITI
Invacare Corp.
Physical Medicine · 19d
Cleared Sep 18, 2001
HARRISON HAND HELD ADJUSTING INSTRUMENT
K010851 · LXM
Harrison Cbp Seminars
Physical Medicine · 181d
Cleared Sep 18, 2001
G7 AUTOMATED HPLC ANALYZER
K011434 · LCP
Tosoh Medics, Inc.
Hematology · 131d
Cleared Sep 18, 2001
HANDPIECE SHEATH-MODEL #A910
K011929 · GEI
Aaron Medical, Inc.
General & Plastic Surgery · 90d
Cleared Sep 18, 2001
DS30 HCY BLOOD COLLECTION TUBES
K012152 · GIM
Drew Scientific , Ltd.
Chemistry · 69d
Cleared Sep 18, 2001
ADVANCE MEDICAL DESIGNS FLUID POUCH
K012168 · KKX
Advance Medical Designs, Inc.
General Hospital · 68d