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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
125521–125544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 22, 1990
INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE GUN
K896933 · KNW
The Witmoore Group, Inc.
Gastroenterology & Urology · 193d
Cleared Jun 22, 1990
MARTIN-HENSLEY SEGMENT LENS
K897021 · HPX
Bruce W. Martin O.D. and Edward Hensley
Ophthalmic · 185d
Cleared Jun 22, 1990
PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER
K900317 · KRB
Elecath
Cardiovascular · 150d
Cleared Jun 22, 1990
SHIELDED PIGGYBACK IV NEEDLE
K900353 · FPA
Pascall Saringia Medical Corp.
General Hospital · 148d
Cleared Jun 22, 1990
O-RING PROSTHETIC ATTACHMENT DEVICE
K900545 · DZE
Calcitek, Inc.
Dental · 137d
Cleared Jun 22, 1990
ACUDATA INDICATENS MODEL 5A
K900596 · GZJ
Acudata Software
Neurology · 134d
Cleared Jun 22, 1990
ACUDATA INDICATENS MODEL 5XS
K900668 · GZJ
Acudata Software
Neurology · 129d
Cleared Jun 22, 1990
MEDILASE SERIES 2100 ENDOSCOPE
K900894 · GCQ
Medical Laser, Inc.
Gastroenterology & Urology · 115d
Cleared Jun 22, 1990
NON-PRESCRIPTION SUNGLASSES
K900936 · HQY
Barkley House, Inc.
Ophthalmic · 114d
Cleared Jun 22, 1990
TRIA-SONIC ULTRA SOUND TRANSMISSION GEL
K901217 · JOT
H & P Industries, Inc.
General & Plastic Surgery · 101d
Cleared Jun 22, 1990
BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON
K901427 · FGE
Telemed Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 22, 1990
ALBERT MORTON UROLOGICAL CATHETER
K901441 · GBM
Transinternational Marketing Group
Gastroenterology & Urology · 87d
Cleared Jun 22, 1990
NUTRICARE ENFUTEC 1000 ENTERAL FEEDING PUMP
K901458 · LZH
Clinical Systems, Inc.
General Hospital · 86d
Cleared Jun 22, 1990
OLYMPIC SMART SCALE PEDIATRICS MODEL 50
K901522 · FRW
Olympic Medical Corp.
General Hospital · 81d