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
100273–100296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1995
AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE...
K954408 · EBF
American Dental Products, Inc.
Dental · 40d
Cleared Oct 30, 1995
THE SILENCER
K954530 · LRK
Silent Knights Ventures, Inc.
Dental · 31d
Cleared Oct 30, 1995
LG HEX PROSTHETICS
K954539 · DZE
The Implant Center of the Palm Beaches
Dental · 52d
Cleared Oct 30, 1995
LASER GAS MIXTURE
K954544 · GEX
Liquid Technology Corp.
General & Plastic Surgery · 31d
Cleared Oct 30, 1995
INCLINOMETER
K954647 · KQX
J-Tech, Inc.
Neurology · 20d
Cleared Oct 30, 1995
PRESSORE MONITOR
K954670 · IKE
Cleveland Medical Devices, Inc.
Physical Medicine · 20d
Cleared Oct 30, 1995
CONNECT
K954689 · EBI
Sybron Dental Specialties, Inc.
Dental · 19d
Cleared Oct 30, 1995
AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING
K954701 · EBC
American Dental Products, Inc.
Dental · 18d
Cleared Oct 30, 1995
IMPLANTALOY
K954702 · EJT
Metalor Dental USA Corp.
Dental · 18d
Cleared Oct 30, 1995
SILANE PRIMER
K954708 · KLE
Sybron Dental Specialties, Inc.
Dental · 18d
Cleared Oct 30, 1995
PEDIATRIC EUROPHYLIC FOLEY CATHETER
K954752 · EZL
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 27, 1995
ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM
K936067 · IYN
Atlantis Diagnostics Intl., Inc.
Radiology · 675d
Cleared Oct 27, 1995
BURGET NASAL STENT
K942025 · LWF
Bivona Medical Technologies
Ear, Nose, Throat · 549d
Cleared Oct 27, 1995
ELECTROCARE
K942631 · GZJ
Waco Corp.
Neurology · 511d
Cleared Oct 27, 1995
EUB-555A+
K945795 · IYO
Hitachi Medical Corp. of America
Radiology · 336d
Cleared Oct 27, 1995
CHEMMATE(TM) KAPPA
K950150 · DFH
Biotek Solutions, Inc.
Immunology · 283d
Cleared Oct 27, 1995
CHEMMATE(TM) UCHL1 (CD45-RO)
K950152 · DFH
Biotek Solutions, Inc.
Immunology · 283d
Cleared Oct 27, 1995
4000+
K950783 · IPF
U.S. Therapy Products, Inc.
Physical Medicine · 248d
Cleared Oct 27, 1995
JC960 2 IN 1 EYEGLASS/CONTACT LENS CASE
K950869 · LRX
Jobar Intl., Inc.
Ophthalmic · 242d
Cleared Oct 27, 1995
PROTIME MICROCOAGULATION SYSTEM
K951072 · GKP
International Technidyne Corp.
Hematology · 233d
Cleared Oct 27, 1995
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ
K951373 · IXW
Fujifilm Medical System U.S.A., Inc.
Radiology · 214d
Cleared Oct 27, 1995
STORZ I/A HANDPIECES
K951463 · HQC
Storz Instrument Co.
Ophthalmic · 211d
Cleared Oct 27, 1995
B-D SPINAL ANESTHESIA TRAY SPINAL
K953467 · CAZ
Bd Becton Dickinson Vacutainer...
Anesthesiology · 95d
Cleared Oct 27, 1995
UNSCENTED MENSTRAL PAD
K953553 · HHD
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 91d