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
152041–152064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 1984
SLOTTED SOFT-TISSUE INSTRUMENT
K841623 · HWQ
Plastafil, Inc.
Orthopedic · 83d
Cleared Jul 11, 1984
OHIO WASTE GAS SCAVENGING RESERVOIR
K841733 · CBN
Ohio Medical Products
Anesthesiology · 76d
Cleared Jul 11, 1984
SPIROLOOP
K841858 · BSE
Datamed, Inc.
Anesthesiology · 68d
Cleared Jul 11, 1984
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
K841864 · DEH
Kallestad Laboratories, Inc.
Immunology · 68d
Cleared Jul 11, 1984
COOK PACEMAKER 215 UNIPOLAR CARDIAC-
K841928 · DXY
Cook Pacemaker Corp.
Cardiovascular · 62d
Cleared Jul 11, 1984
COOK PACEMAKER 216 BIPOLAR CARDIAC -
K841983 · DXY
Cook Pacemaker Corp.
Cardiovascular · 57d
Cleared Jul 11, 1984
H-TYPE BRIDGE REMOVER
K842026 · EIS
Higa Manufacturing , Ltd.
Dental · 54d
Cleared Jul 11, 1984
IL 1312, PH BLOOD GAS MANAGER
K842042
Instrumentation Laboratory CO
Chemistry · 51d
Cleared Jul 11, 1984
FIAX TRANSFERRIN TEST KIT
K842071 · DDI
Intl. Diagnostic Technology
Immunology · 49d
Cleared Jul 11, 1984
STRATUS PRIMIDONE FLOROMETRIC ENZY
K842196 · LFT
American Dade
Toxicology · 37d
Cleared Jul 11, 1984
LEAP LE TEST KIT
K842484 · LKJ
Cooper Biomedical, Inc.
Immunology · 16d
Cleared Jul 11, 1984
BIRD HEATED HUMIDIFIER 3201
K842523 · BTT
3M Company
Anesthesiology · 14d
Cleared Jul 11, 1984
SHERIDAN/INTENSA TUBE
K842558 · BTR
Sheridan Catheter Corp.
Anesthesiology · 9d
Cleared Jul 11, 1984
STREP-A-CHEK
K842600 · JSF
E-Y Laboratories, Inc.
Microbiology · 8d
Cleared Jul 10, 1984
BECTON DICKINSON 1000 INSULIN PUMP
K842685
Bd Becton Dickinson Vacutainer...
General Hospital
Cleared Jul 09, 1984
SILA CLEAN 20/20
K832327
Professional Supplies, Inc.
Ophthalmic · 360d
Cleared Jul 09, 1984
OSTOMY FREEDOM KIT
K841173 · EXB
Ellenberg Assoc.
Gastroenterology & Urology · 112d
Cleared Jul 09, 1984
CYSTO-AID
K841197 · KNX
E-Z-Em, Inc.
Gastroenterology & Urology · 110d
Cleared Jul 09, 1984
HALO CO LASER SYSTEM
K841234 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 109d
Cleared Jul 09, 1984
FOREIGN BODY PROTECTOR
K841258 · FED
Jayco Pharmaceuticals
Gastroenterology & Urology · 105d
Cleared Jul 09, 1984
JEJUNOSTOMY SET FOR TUBE FEEDING
K841428 · KNT
Burron Medical Products, Inc.
Gastroenterology & Urology · 94d
Cleared Jul 09, 1984
AMER. PHARMASEAL SILICONIZED LATEX
K841544 · KOD
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 84d
Cleared Jul 09, 1984
PLUME FISTULA NEEDLE
K841791 · FIQ
Hospal Medical Corp.
Gastroenterology & Urology · 70d
Cleared Jul 09, 1984
VARIAN 3300 & 3400 GAS CHROMATOGRAPHS
K841891 · KZQ
Varian Assoc., Inc.
Chemistry · 63d