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
82753–82776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 2000
INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000
K994270 · LLZ
Visualization Technology, Inc.
Radiology · 80d
Cleared Mar 08, 2000
VOYAGER/VIPER WHEELCHAIR
K000497 · IOR
Otto Bock Orthopedic Industry, Inc.
Physical Medicine · 22d
Cleared Mar 08, 2000
LUER ACCESS UNIVERSAL VIAL ADAPTER
K000657 · FMI
Baxter Healthcare Corp
General Hospital · 9d
Cleared Mar 08, 2000
BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE
K982558 · FOZ
Bd/Preefil
General Hospital · 595d
Cleared Mar 08, 2000
ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
K990718 · GEX
Laserscope
General & Plastic Surgery · 370d
Cleared Mar 08, 2000
SUPERGUARD SAFETY SYRINGE
K990831 · MEG
U.S. Safety Syringes Co., Inc.
General Hospital · 362d
Cleared Mar 08, 2000
OOCYTE ASPIRATION NEEDLE
K991271 · MQE
Casmed UK
Obstetrics & Gynecology · 330d
Cleared Mar 08, 2000
CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING,...
K992912 · DRF
Cardiac Pathways Corp.
Cardiovascular · 191d
Cleared Mar 08, 2000
LEMAITRE IRRIGATION CATHETER
K992933 · DXE
Vascutech, Inc.
Cardiovascular · 190d
Cleared Mar 08, 2000
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K993691 · FOZ
Arrow Intl., Inc.
General Hospital · 128d
Cleared Mar 08, 2000
LIFECORE SINGLE TOOTH ABUTMENT SYSTEM
K993894 · DZE
Lifecore Biomedical, Inc.
Dental · 113d
Cleared Mar 08, 2000
KAWASUMI LABORATORIES PHILEBOTOMY SET
K994323 · LHI
Kawasumi Laboratories Co., Ltd.
General Hospital · 77d
Cleared Mar 08, 2000
HORIZON LIGHT
K994375 · FRN
B.Braun Medical, Inc.
General Hospital · 72d
Cleared Mar 07, 2000
CAUTERY FORCEPS WITH FOOTSWITCH
K000250 · GEI
Starion Instruments
General & Plastic Surgery · 40d
Cleared Mar 07, 2000
ELECSYS CORTISOL TEST SYSTEM
K000270 · JJY
Roche Diagnostics Corp.
Chemistry · 39d
Cleared Mar 07, 2000
STARION CAUTERY HOOK
K000296 · GEI
Starion Instruments
General & Plastic Surgery · 36d
Cleared Mar 07, 2000
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K000397 · FHN
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Mar 07, 2000
ISOBAR SPINAL SYSTEM
K000425 · MNI
Encore Orthopedics, Inc.
Orthopedic · 27d
Cleared Mar 07, 2000
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI...
K000447 · LAF
Phamatech
Toxicology · 26d
Cleared Mar 07, 2000
MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K000513 · KWQ
Ebi, L.P.
Orthopedic · 20d
Cleared Mar 07, 2000
SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM
K000608 · GDW
Std Mfg., Inc.
General & Plastic Surgery · 13d
Cleared Mar 07, 2000
MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM
K991470 · MQL
Medicult A/S
Obstetrics & Gynecology · 328d
Cleared Mar 07, 2000
ALLON 2000
K992386 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 235d
Cleared Mar 07, 2000
SAS STREP A TEST
K993456 · GTY
Sa Scientific, Inc.
Microbiology · 146d