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
84217–84240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1999
BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT
K993138 · KNT
Ballard Medical Products
Gastroenterology & Urology · 30d
Cleared Oct 20, 1999
QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178
K993165 · DJG
Phamatech
Toxicology · 28d
Cleared Oct 19, 1999
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
K990141 · GQW
Light Diagnostics
Microbiology · 273d
Cleared Oct 19, 1999
TES-20
K992425 · MWJ
Tes Electrical Electronic Corp.
Cardiovascular · 90d
Cleared Oct 19, 1999
PASCO MIC AND MIC/ID PANELS, PENICILLIN
K992646 · JTN
Pasco Laboratories, Inc.
Microbiology · 74d
Cleared Oct 19, 1999
PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN
K992647 · JTN
Pasco Laboratories, Inc.
Microbiology · 74d
Cleared Oct 19, 1999
MCL 29 DERMABLATE ER:YAG LASER SYSTEM
K992707 · GEX
Aesculap-Meditec North America
General & Plastic Surgery · 69d
Cleared Oct 19, 1999
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
K992880 · LJT
Sims Deltec, Inc.
General Hospital · 53d
Cleared Oct 18, 1999
DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE
K990752 · LZA
Wrp Specialty Products Sdn. Bhd.
General Hospital · 224d
Cleared Oct 18, 1999
VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2
K991239 · ELC
Micron Corp.
Dental · 189d
Cleared Oct 18, 1999
OPAP
K991926 · BZD
Opap, Inc.
Anesthesiology · 133d
Cleared Oct 18, 1999
RAPIDONE-AMPHETAMINE TEST
K992452 · DOD
American Bio Medica Corp.
Toxicology · 88d
Cleared Oct 18, 1999
HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE...
K992523 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 82d
Cleared Oct 18, 1999
PHILIPS GYROSCAN INTERA (*)
K992533 · LNH
Philips Medical Systems North...
Radiology · 81d
Cleared Oct 18, 1999
FETAL ASSESSMENT CAP
K992580 · IYO
Acuson Corp.
Radiology · 77d
Cleared Oct 18, 1999
EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS
K992692 · LPL
Benz Research and Development Corp.
Ophthalmic · 68d
Cleared Oct 18, 1999
INSURE PRO TEST
K992695 · JHI
Inbios Intl., Inc.
Chemistry · 68d
Cleared Oct 18, 1999
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
K992723 · CAC
Transfusion Technologies Corp.
Anesthesiology · 66d
Cleared Oct 18, 1999
N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL...
K992766 · MRR
Genzyme Corp.
Chemistry · 62d
Cleared Oct 18, 1999
HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT,...
K992845 · JIX
Elan Holdings, Inc.
Chemistry · 55d
Cleared Oct 18, 1999
HICHEM TOTAL PROTEIN REAGENT
K992846 · CEK
Elan Holdings, Inc.
Chemistry · 55d
Cleared Oct 18, 1999
REP CHOLESTEROL PROFILE KIT
K992971 · JHO
Helena Laboratories
Chemistry · 45d
Cleared Oct 18, 1999
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50
K993178 · CDQ
Diagnostic Chemicals , Ltd.
Chemistry · 25d
Cleared Oct 15, 1999
DAIWA MODEL 180
K983616 · DXN
Daiwa Products, Inc.
Cardiovascular · 366d