FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126097–126120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 1990
OPUS(TM) DIGOXIN TEST SYSTEM
K901547 · KXT
Pb Diagnostic Systems, Inc.
Toxicology · 84d
Cleared Jun 26, 1990
NEW PER-FIT(R) IMPROVED
K901621 · EBI
Dental Product Co.
Dental · 82d
Cleared Jun 26, 1990
RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT
K901779 · IPF
Rich-Mar Corp.
Physical Medicine · 70d
Cleared Jun 26, 1990
HELIO LINK (RESIN CEMENT)
K901910 · EBF
Ivoclar North America, Inc.
Dental · 61d
Cleared Jun 26, 1990
SYNTAC (DENTIN BONDING AGENT)
K901913 · KLE
Ivoclar North America, Inc.
Dental · 61d
Cleared Jun 26, 1990
HELIOTINT
K901918 · EBF
Ivoclar North America, Inc.
Dental · 61d
Cleared Jun 26, 1990
OPUS (TM) HCG
K901935 · JHI
Pb Diagnostic Systems, Inc.
Toxicology · 57d
Cleared Jun 26, 1990
OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02
K901963 · JEQ
Omron Marshall Products, Inc.
Dental · 56d
Cleared Jun 26, 1990
WHITESIDE ORTHOLOC MODULAR POST. STAB. KNEE SYSTEM
K901992 · JWH
Dow Corning Wright
Orthopedic · 55d
Cleared Jun 26, 1990
P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT
K902137 · JDI
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 46d
Cleared Jun 26, 1990
MODIFIED STICK-GARD SAFETY NEEDLE
K902196 · FPA
Ziehm International, Inc.
General Hospital · 41d
Cleared Jun 26, 1990
MONITOR, MODEL 2817
K902334 · DXJ
Esaote Biomedica Spa
Cardiovascular · 33d
Cleared Jun 26, 1990
DISPOSABLE CORONARY CONTROL SYRINGE
K902346 · FMF
Advance Medical Designs, Inc.
General Hospital · 32d
Cleared Jun 26, 1990
RUBIN PATIENT EXAMINATION GLOVES
K902463 · LYY
P.T. Perkebunan
General Hospital · 22d
Cleared Jun 26, 1990
ECKHARDT TEMPORARY KERATOPROSTHESIS
K902491 · MLP
Dutch Ophthalmic USA, Inc.
Ophthalmic · 21d
Cleared Jun 26, 1990
HARE FOLDING BACK EMERGENCY STRETCHER
K902503 · FPO
Dyna Corp.
General Hospital · 21d
Cleared Jun 25, 1990
ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS
K896106 · KWP
Richards Medical Co., Inc.
Orthopedic · 248d
Cleared Jun 25, 1990
KNIGHTWATCH SYSTEM
K896934 · BZQ
Createch Corp.
Anesthesiology · 194d
Cleared Jun 25, 1990
SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS
K900512 · DTD
Pacesetter Systems
Cardiovascular · 143d
Cleared Jun 25, 1990
700 SERIES BIOMAGNETOMETER
K901215 · OLX
Biomagnetic Technologies, Inc.
Neurology · 103d
Cleared Jun 25, 1990
POSTEROMEDIAL GUIDE
K901765 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 68d
Cleared Jun 25, 1990
HALL MODULAR ACETABULAR REAMER SYSTEM
K902332 · HWE
Zimmer, Inc.
Orthopedic · 32d
Cleared Jun 22, 1990
CONTINUOUS IRRIGATION RESECTOSCOPE SYST/GYNECOLOGY
K895857 · HIH
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 262d
Cleared Jun 22, 1990
INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE
K896932 · FCG
The Witmoore Group, Inc.
Gastroenterology & Urology · 193d