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
129289–129312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1989
FIAX EB VCA-M TEST KIT
K894932 · LSE
Whittaker Bioproducts, Inc.
Microbiology · 74d
Cleared Oct 16, 1989
SLT CONTACT LASER SYSTEMS FOR PHOTOCOAGULATION
K895029 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 69d
Cleared Oct 16, 1989
OPTICAL CATHETER(TM) INTRODUCER SETS
K895041 · KGZ
Medical Dynamics, Inc.
General & Plastic Surgery · 68d
Cleared Oct 16, 1989
MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR
K895196 · HQF
Nidek, Inc.
Ophthalmic · 66d
Cleared Oct 16, 1989
VIBRA-TRAC TRACTION TABLE
K895382 · ILZ
Vibra-Trac Industries
Physical Medicine · 47d
Cleared Oct 16, 1989
COBAS READY GLUCOSE REAGENT
K895526 · CGA
Roche Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Oct 16, 1989
SMALL JOINT HAND INSTRUMENTS
K895685 · HRX
Leonard Medical, Inc.
Orthopedic · 24d
Cleared Oct 16, 1989
FORTRESS MODEL 2001LX ELECTRIC 3-WHEELER
K895692 · INI
Fortress Scientific , Ltd.
Physical Medicine · 24d
Cleared Oct 13, 1989
FREEMAN TOTAL HIP SYSTEM RIDGED STEM
K890331 · LWJ
Orthopedic Systems, Inc.
Orthopedic · 263d
Cleared Oct 13, 1989
FREEMAN MODULAR HIP STEM RIDGED VERSION
K890498 · JDI
Orthopedic Systems, Inc.
Orthopedic · 254d
Cleared Oct 13, 1989
NON-REBREATHING AIRWAY AND MASK(S) KITS
K891124 · CBP
Airway Products, Inc.
Anesthesiology · 224d
Cleared Oct 13, 1989
MIC NON-STERILE LATEX GLOVES
K891160 · LYY
Asia Dynamics, Inc.
General Hospital · 221d
Cleared Oct 13, 1989
POCKETED WRAPS #3009 A,B,C
K891210 · KCT
Pro-Safe Professional Linens, Inc.
General Hospital · 220d
Cleared Oct 13, 1989
ELECTRO-PHYSIO-FEEDBACK-XRROID* SYSTEM
K892114 · HCC
Eclosion, Inc.
Neurology · 197d
Cleared Oct 13, 1989
PATIENT EXAMINATION GLOVES
K892311 · LYY
Southern Rubber Industries Co., Ltd.
General Hospital · 190d
Cleared Oct 13, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892313 · LYY
Glove Lines Private , Ltd.
General Hospital · 190d
Cleared Oct 13, 1989
ANESTHETIC AGENT MONITOR
K892854 · CBQ
Criticare Systems, Inc.
Anesthesiology · 178d
Cleared Oct 13, 1989
ENEMA KIT
K894209 · KPL
Ledins Herbal Healing Systems
Gastroenterology & Urology · 116d
Cleared Oct 13, 1989
NIPRO DENTAL NEEDLE
K894373 · DZM
Pharma-Plast USA, Inc.
Dental · 88d
Cleared Oct 13, 1989
DEVILBISS MODEL 6610D
K894441 · CCQ
Devilbiss Health Care, Inc.
Anesthesiology · 88d
Cleared Oct 13, 1989
CARNATION TRACHEOSTOMY MASKS
K894457 · BYF
Dadsun Corp., Ltd.
Anesthesiology · 87d
Cleared Oct 13, 1989
LIGHT BOND SEALANT WITH FLUORIDE
K894565 · DYH
Reliance Orthodontic Products, Inc.
Dental · 84d
Cleared Oct 13, 1989
UNIVERSAL LIGHT CABLE
K894570 · LDQ
Expanded Optics, Inc.
General & Plastic Surgery · 84d
Cleared Oct 13, 1989
MICRO-AIRE HIGH SPEED DRILL (2910-000)
K894606 · EFB
Micro-Aire Surgical Instruments, Inc.
Dental · 85d