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
128689–128712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1989
TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN
K894261 · GMN
Microbix Biosystems, Inc.
Microbiology · 117d
Cleared Oct 16, 1989
RUBELLA ANTIGEN AND CONTROL ANTIGEN
K894262 · GON
Microbix Biosystems, Inc.
Microbiology · 117d
Cleared Oct 16, 1989
IMMUNODOT RUBELLA TEST
K894546 · LFX
General Biometrics, Inc.
Microbiology · 87d
Cleared Oct 16, 1989
CLP CK/LD ISOENZYME CONTROL
K894554 · JJT
Creative Laboratory Products, Inc.
Chemistry · 88d
Cleared Oct 16, 1989
RESPIRATORY SYNCYTIAL VIRUS
K894623 · LKT
Bion Ent., Ltd.
Microbiology · 88d
Cleared Oct 16, 1989
MUMPS VIRUS
K894624 · GRA
Bion Ent., Ltd.
Microbiology · 88d
Cleared Oct 16, 1989
EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN
K894626 · LLM
Bion Ent., Ltd.
Microbiology · 88d
Cleared Oct 16, 1989
IMMUNO/ASO
K894780 · GTQ
Immunostics Co., Inc.
Microbiology · 81d
Cleared Oct 16, 1989
UNSCENTED MENSTRUAL TAMPON
K894846 · HEB
Personal Products Co.
Obstetrics & Gynecology · 77d
Cleared Oct 16, 1989
MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK
K894914 · JGS
I-Stat Corp.
Chemistry · 75d
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