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
91585–91608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1997
WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET
K971683 · MSX
Marquette Electronics, Inc.
Cardiovascular · 168d
Cleared Oct 22, 1997
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K971989 · LGD
Bayer Corp.
Microbiology · 146d
Cleared Oct 22, 1997
FINALLY FREE
K972695 · KCX
Mehl/Group Marketing
General & Plastic Surgery · 96d
Cleared Oct 22, 1997
LINK, ACETABULAR REVISION MESH CUP
K972760 · JDJ
Link America, Inc.
Orthopedic · 90d
Cleared Oct 22, 1997
ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
K972836 · LTZ
G. Premjee (Usa), Inc.
Obstetrics & Gynecology · 83d
Cleared Oct 22, 1997
MDP2000 MEDICAL DATA PROCESSOR
K972880 · MSX
Vidco, Inc.
Cardiovascular · 78d
Cleared Oct 22, 1997
TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING
K973312 · MGP
Innovative Technologies , Ltd.
General & Plastic Surgery · 49d
Cleared Oct 22, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN...
K973331 · DBF
Ortho-Clinical Diagnostics, Inc.
Immunology · 48d
Cleared Oct 22, 1997
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
K973464 · DHR
Instrumentation Laboratory CO
Immunology · 40d
Cleared Oct 22, 1997
LIQUID ALKALINE PHOSHATASE REAGENT SET
K973588 · CJE
Pointe Scientific, Inc.,
Chemistry · 30d
Cleared Oct 21, 1997
FEMASSIST URINARY DEVICE
K963858 · MNG
Insight Medical Corp.
Gastroenterology & Urology · 391d
Cleared Oct 21, 1997
HISTOFREEZER VERRUCA PLANA
K971392 · GEH
OraSure Technologies, Inc.
General & Plastic Surgery · 189d
Cleared Oct 21, 1997
NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND...
K971436 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 186d
Cleared Oct 21, 1997
SERAQUEST TOXOPLASMA IGM
K971672 · LGD
Quest Intl., Inc.
Microbiology · 167d
Cleared Oct 21, 1997
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)
K971897 · LFK
Medron, Inc.
Gastroenterology & Urology · 152d
Cleared Oct 21, 1997
BOVIE MODEL X40
K972071 · GEI
Maxxim Medical
General & Plastic Surgery · 140d
Cleared Oct 21, 1997
REGENESIS MODEL 42
K972093 · ILX
Regenesis Biomedical, Inc.
Physical Medicine · 139d
Cleared Oct 21, 1997
DIGIFLEX SURGICAL GLOVES
K972277 · KGO
Hms Services, Inc.
General Hospital · 125d
Cleared Oct 21, 1997
AUTO-LYTE COTININE EIA
K972481 · MKU
OraSure Technologies, Inc.
Toxicology · 111d
Cleared Oct 21, 1997
TITANIUM HEMOSTATIC CLIP
K972745 · MCH
Eisner USA, Inc.
General & Plastic Surgery · 90d
Cleared Oct 21, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100
K972746 · DPS
Alexander Mfg. Co.
Cardiovascular · 90d
Cleared Oct 21, 1997
DURACON CONVERSION METAL BACKED PATELLA
K972752 · JWH
Howmedica Corp.
Orthopedic · 90d
Cleared Oct 21, 1997
NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER
K972765 · GEX
American Laser Medical
General & Plastic Surgery · 89d
Cleared Oct 21, 1997
ADVANCE ULTRA-CONGRUENT TIBIAL INSERT
K972770 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 89d