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
95785–95808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1996
ELECTROSURGICAL PROBE
K963901 · GEI
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 38d
Cleared Nov 04, 1996
RESOUND CC4 PERSONAL HEARING SYSTEM
K964115 · ESD
Resound Corp.
Ear, Nose, Throat · 20d
Cleared Nov 01, 1996
GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
K943824 · CCL
Ametek, Inc.
Anesthesiology · 914d
Cleared Nov 01, 1996
NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
K961272 · LOS
Nihon Kohden America, Inc.
Cardiovascular · 213d
Cleared Nov 01, 1996
AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM
K961705 · GEX
Applied Optronics Corp.
General & Plastic Surgery · 183d
Cleared Nov 01, 1996
AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM
K961710 · GEX
Applied Optronics Corp.
General & Plastic Surgery · 183d
Cleared Nov 01, 1996
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
K961836 · DTN
Medtronic Vascular
Cardiovascular · 172d
Cleared Nov 01, 1996
SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER
K961935 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 165d
Cleared Nov 01, 1996
WELLCOLEX E-COLI OI57 ZC60
K962028 · GNA
Murex Diagnostics, Inc.
Microbiology · 162d
Cleared Nov 01, 1996
COMBILINES HEMODIALYSIS BLOOD TUBING SET
K962081 · FJK
National Medical Care, Medical...
Gastroenterology & Urology · 157d
Cleared Nov 01, 1996
KARL STORZ REMORGIDA FORCEPS
K962083 · KNS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 156d
Cleared Nov 01, 1996
SCUBA SYSTEM
K962482 · HIH
Gynecare, Inc.
Obstetrics & Gynecology · 128d
Cleared Nov 01, 1996
SLEEPNET HUMIDIFIER,(84200 PACKAGED)
K963025 · BTT
Sleepnet Corporation
Anesthesiology · 88d
Cleared Nov 01, 1996
FEMTEX GENTLE TOUCH TAMPONS
K963034 · HEB
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 88d
Cleared Nov 01, 1996
MICRO SPIROMETER
K963035 · BZG
Micro Direct, Inc.
Anesthesiology · 88d
Cleared Nov 01, 1996
INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853
K963042 · CAW
Sim Italia S.R.L.
Anesthesiology · 88d
Cleared Nov 01, 1996
ENDOCAM
K963046 · GCJ
Corin USA
General & Plastic Surgery · 88d
Cleared Nov 01, 1996
HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET
K963099 · FMQ
Heelbo, Inc.
General Hospital · 84d
Cleared Nov 01, 1996
HEELBO PELVIC RESTRAINT
K963199 · FMQ
Hollister, Inc.
General Hospital · 78d
Cleared Nov 01, 1996
RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM
K963550 · KMA
Respironics, Inc.
Ear, Nose, Throat · 57d
Cleared Nov 01, 1996
ALPCO/MERCODIA INSULIN ELISA
K963911 · CFP
American Laboratory Products Co., Ltd.
Chemistry · 32d
Cleared Nov 01, 1996
STP SYSTEM-PVA WITH MERCURY
K964027 · LIO
Sage Products, Inc.
Microbiology · 25d
Cleared Nov 01, 1996
HEMOCUE GLUCOTROL
K964053 · JJX
Direct Solutions
Chemistry · 32d
Cleared Oct 31, 1996
TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE
K960590 · LYY
Aladan Corp.
General Hospital · 262d