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
140353–140376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 1987
SUPER SCISSORS
K870763
Treace Medical, Inc.
General & Plastic Surgery · 20d
Cleared Mar 18, 1987
SCHUKNECHT WIRE CUTTING SCISSORS
K870764
Treace Medical, Inc.
General & Plastic Surgery · 20d
Cleared Mar 18, 1987
TRU-STIM MUSCLE STIMULATOR
K870774 · IPF
Briefcase, Inc.
Physical Medicine · 20d
Cleared Mar 18, 1987
A.T.S. 1500 TOURNIQUET
K870784 · KCY
Aspen Laboratories, Inc.
General & Plastic Surgery · 20d
Cleared Mar 18, 1987
NOTCH-NEEDLE, WESCOTT STYLE
K870896 · GAA
Ocean Medical Products, Ltd.
General & Plastic Surgery · 13d
Cleared Mar 18, 1987
ULTRA-LUX LIGHT SOURCE
K870898 · FSW
Medline Industries, Inc.
General & Plastic Surgery · 13d
Cleared Mar 17, 1987
DIAMOND MEDICAL, INC., MODEL DM 700
K863298 · FFT
Diamond Medical, Inc.
Gastroenterology & Urology · 204d
Cleared Mar 17, 1987
BODY WATCH BODY COMPOSITION ANALYZER MODEL 2010
K863833 · DSB
Body Watch, Inc.
Cardiovascular · 168d
Cleared Mar 17, 1987
VETA/VENTED ESOPHAGEAL TUBE AIRWAY
K864200 · CAO
Cranco Co.
Anesthesiology · 141d
Cleared Mar 17, 1987
HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI
K864265 · KPO
Dial Medical of Florida, Inc.
Gastroenterology & Urology · 139d
Cleared Mar 17, 1987
PERSONAL INFUSION PUMP
K864276 · FRN
Bionica, Inc.
General Hospital · 139d
Cleared Mar 17, 1987
DELTATRAC(TM) METABOLIC MONITOR
K864603 · BZL
Datex Division Instrumentarium Corp.
Anesthesiology · 113d
Cleared Mar 17, 1987
ALLERG*ENS ENZYME IMMUNOASSAY KIT
K864696 · DHB
Dexall Biomedical Labs, Inc.
Immunology · 106d
Cleared Mar 17, 1987
NORFLOXACIN 10 MCG SENSI DISC
K864756 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 102d
Cleared Mar 17, 1987
NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK
K864848 · JTN
Organon Teknika Corp.
Microbiology · 97d
Cleared Mar 17, 1987
UNI-PULS(TENS) MODEL #292
K865063 · GZJ
Oms Medico, Inc.
Neurology · 83d
Cleared Mar 17, 1987
ACCUPEN(R)
K870078 · FMF
Ulster Scientific, Inc.
General Hospital · 68d
Cleared Mar 17, 1987
IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT
K870089 · GTJ
Microscan Div. Baxter Healthcare Corp.
Microbiology · 67d
Cleared Mar 17, 1987
MODIFIED JIMMY JOHN III
K870127 · KPL
Colon Therapeutics
Gastroenterology & Urology · 67d
Cleared Mar 17, 1987
CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER
K870233 · GKZ
Abbott Diagnostics
Hematology · 55d
Cleared Mar 17, 1987
DACOMED PENILE PROSTHESIS SIZER
K870320 · JLW
Dacomed Corp.
Chemistry · 48d
Cleared Mar 17, 1987
NORFLOXACIN 10 MCG SENSITIVITY DISKS
K870348 · JTN
Difco Laboratories, Inc.
Microbiology · 48d
Cleared Mar 17, 1987
JIMMY JOHN III, COLONIC IRRIGATION SYSTEM
K870376 · KPL
Colon Therapeutics
Gastroenterology & Urology · 47d
Cleared Mar 17, 1987
MYA-1 AND MYT-1 MYELOGRAM TRAY
K870418
North Coast Medi-Tek
Cardiovascular · 42d