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
118753–118776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1991
AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY
K914230 · JWH
Orthomet, Inc.
Orthopedic · 87d
Cleared Dec 16, 1991
FRAMES (SPECTACLES)
K914239 · HQZ
Jane Fui Optical Co., Ltd.
Ophthalmic · 89d
Cleared Dec 16, 1991
ASL MODEL #102
K914739 · ITI
Adaptive Switch Laboratories, Inc.
Physical Medicine · 56d
Cleared Dec 16, 1991
ASL MODEL #103
K914740 · ITI
Adaptive Switch Laboratories, Inc.
Physical Medicine · 56d
Cleared Dec 16, 1991
PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA
K915200 · JHI
Becton Dickinson Advanced Diagnostics
Chemistry · 27d
Cleared Dec 13, 1991
LIFESHIELD EXTENSION SET
K912103 · FPK
Abbott Laboratories
General Hospital · 214d
Cleared Dec 13, 1991
AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM
K912908 · LBI
Air-Shields Vickers, Inc.
General Hospital · 164d
Cleared Dec 13, 1991
MENTOR INFUSION LINE
K912919 · KNY
Mentor Corp.
Gastroenterology & Urology · 163d
Cleared Dec 13, 1991
TTU-100THERMAL THERAPY UNIT
K913026 · ILO
Danninger Medical Technology, Inc.
Physical Medicine · 157d
Cleared Dec 13, 1991
INFLUENZA MAB TEST/INFLUENZA B TEST
K913214 · GNW
Gull Laboratories, Inc.
Microbiology · 147d
Cleared Dec 13, 1991
RINN E-Z CAPPER
K913885 · FMI
Rinn Corp.
General Hospital · 106d
Cleared Dec 13, 1991
VIVUS PS (PROGRAMMING SOFTWARE)
K913907 · FRN
I-Flow Corp.
General Hospital · 105d
Cleared Dec 13, 1991
IMMUCHEM NEONATAL TSH-MP ELISA
K913963 · JLW
Icn Biomedicals, Inc.
Chemistry · 99d
Cleared Dec 13, 1991
ONTRAC
K914138 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 88d
Cleared Dec 13, 1991
FEMORAL ARTERY PRESSURE PAD/DISK
K914149 · DXC
Disco, Inc.
Cardiovascular · 88d
Cleared Dec 13, 1991
DRESSING/CVP DRESSING CHANGE/HYPERALIMENT TRAYS
K914157 · LYY
Cml, Inc.
General Hospital · 88d
Cleared Dec 13, 1991
ASCENTEC MEDICZAL SYSTEMS LAPAROSCOPIC ELECTRODE
K914252 · GEI
Ascentec Medical Systems
General & Plastic Surgery · 81d
Cleared Dec 13, 1991
CREATINE KINASE MB TEST ITEM NUMBER 5A46
K914361 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 73d
Cleared Dec 13, 1991
DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR
K914917 · JIX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 39d
Cleared Dec 12, 1991
MODIF. LASERFLO BLOOD PERFUSION MONITOR MODEL BPM2
K912446 · DPW
Vasamedics, LLC
Cardiovascular · 192d
Cleared Dec 12, 1991
ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING
K913636 · JXG
Cordis Corp.
Neurology · 119d
Cleared Dec 11, 1991
DP 100
K911192 · CAF
Ferguson Medical
Anesthesiology · 268d
Cleared Dec 11, 1991
LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM
K912165 · FOZ
Menlo Care, Inc.
General Hospital · 209d
Cleared Dec 11, 1991
ITC HIESHIMA TAPER SELECT(TM) PERCUTANEOUS CATH
K912532 · DQO
Interventional Therapeutics Corp.
Cardiovascular · 187d