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
87769–87792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1998
HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
K980799 · EBG
Cosmedent, Inc.
Dental · 240d
Cleared Oct 28, 1998
CLEARPLAN EASY FERTILITY MONITOR
K981207 · NGE
Unipath , Ltd.
Chemistry · 209d
Cleared Oct 28, 1998
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K981528 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 182d
Cleared Oct 28, 1998
HANDISOL WOUND HEALING
K982082 · FTC
National Biological Corp.
General & Plastic Surgery · 135d
Cleared Oct 28, 1998
SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
K982225 · BTL
Spiracle Technology
Anesthesiology · 126d
Cleared Oct 28, 1998
VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608
K982541 · FMI
Becton Dickinson Vacutainer Systems
General Hospital · 99d
Cleared Oct 28, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE...
K982662 · HWC
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Oct 28, 1998
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
K982693 · FYA
Medline Industries, Inc.
General Hospital · 86d
Cleared Oct 28, 1998
MAICO MA42
K982723 · EWO
Bernafon-Maico, Inc.
Ear, Nose, Throat · 84d
Cleared Oct 28, 1998
OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE
K982733 · ITX
The Olympus Optical Co.
Radiology · 84d
Cleared Oct 28, 1998
PIEZO TRONIC
K982793 · ELC
Advanced Medical Devices, Inc.
Dental · 79d
Cleared Oct 28, 1998
SHELHIGH NO-REACT VASCUPATCH
K982810 · DXZ
Shelhigh, Inc.
Cardiovascular · 78d
Cleared Oct 28, 1998
MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
K982970 · EZL
Mri Manufacturing and Research, Inc.
Gastroenterology & Urology · 64d
Cleared Oct 28, 1998
AUROLLOYD KF
K983080 · EJT
Bego U.S.A.
Dental · 56d
Cleared Oct 28, 1998
BEGOPAL 300
K983081 · EJS
Bego Bremer Goldschlaegerei Wilh....
Dental · 56d
Cleared Oct 28, 1998
BEGOCER G
K983082 · EJT
Bego U.S.A.
Dental · 56d
Cleared Oct 28, 1998
ELAN-2
K983091 · EBF
Kerr Dental Materials Center
Dental · 55d
Cleared Oct 28, 1998
MEPILEX
K983184 · MGP
Molnlycke Health Care, Inc.
General & Plastic Surgery · 47d
Cleared Oct 28, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1
K983709 · DIF
Beckman Coulter, Inc.
Toxicology · 7d
Cleared Oct 27, 1998
PIOLAX HYDROPHILIC GUIDEWIRE
K980977 · DQX
Piolax Medical Devices, Inc.
Cardiovascular · 225d
Cleared Oct 27, 1998
ELECSYS PSA, MODEL # ELECSYS 1010
K982948 · LTJ
Boehringer Mannheim Corp.
Immunology · 67d
Cleared Oct 27, 1998
ELECSYS PSA, MODEL 2010
K982949 · LTJ
Boehringer Mannheim Corp.
Immunology · 67d
Cleared Oct 27, 1998
SUMMIT ACETABULAR SYSTEM
K983014 · LPH
Johnson & Johnson Professionals, Inc.
Orthopedic · 60d
Cleared Oct 27, 1998
OSTEO DYNATROC PROXIMAL FEMORAL NAIL
K983339 · HSB
Osteonics Corp.
Orthopedic · 34d