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
153337–153360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 1984
NML CORTISOL RIA
K840466 · CGR
Nuclear Medical Laboratories, Inc.
Chemistry · 56d
Cleared Mar 30, 1984
PARTIAL PRESS. ELECTRODE MEASUREMENT
K840468 · CHL
Shaban Mfg. Co.
Chemistry · 56d
Cleared Mar 30, 1984
BEHING-THE-EAR HEARING AID T-85D
K840479 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 56d
Cleared Mar 30, 1984
BEHIND THE EAR HEARING AID T-97
K840480 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 56d
Cleared Mar 30, 1984
SUPPLIES FOR INSTRUMENTATION LAB FLAME
K840530 · JJO
Shaban Mfg. Co.
Chemistry · 65d
Cleared Mar 30, 1984
IN-THE-EAR HEARING AID
K840559 · ESD
Emtronics, Inc.
Ear, Nose, Throat · 51d
Cleared Mar 30, 1984
MINI-PUMP U-100
K840616 · FRN
Advanced Bio Systems, Inc.
General Hospital · 46d
Cleared Mar 30, 1984
THERMOCRAFT PORCELAIN
K840642 · ELL
American Thermocraft Corp.
Dental · 44d
Cleared Mar 30, 1984
UNIVERSAL OXYGEN TUBING CONNECTOR
K840790 · BYX
Cherry Plastics, Inc.
Anesthesiology · 56d
Cleared Mar 30, 1984
ORAL SAFE
K840805 · JER
Great Lakes Orthodontics, Ltd.
Dental · 35d
Cleared Mar 30, 1984
SERIES MR IN-THE-EAR CUSTOM HEARING AID
K840825 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Mar 30, 1984
MMG CONNECTIVE TUBING
K840838 · GAZ
Medical Marketing Group
General Hospital · 35d
Cleared Mar 30, 1984
HEARING AID UNITRON UE8
K840842 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 35d
Cleared Mar 30, 1984
BEHIND-THE-EAR HEARING AID 2000
K840871 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 32d
Cleared Mar 30, 1984
QUIK LOK
K840878 · FPA
Abbott Laboratories
General Hospital · 32d
Cleared Mar 30, 1984
IVY COMMANDEER
K840942 · LDR
Ivy Medical, Inc.
General Hospital · 25d
Cleared Mar 30, 1984
MEDEVICE V-80 VACUUM PUMP
K840952 · HHI
Berkeley Medevices
Obstetrics & Gynecology · 25d
Cleared Mar 30, 1984
COLE TUBE-LATEX
K840973 · BTR
Inmed Corp.
Anesthesiology · 24d
Cleared Mar 30, 1984
RICO RESPIRATION MONITOR
K840975 · BZK
J.M. Laboratories, Inc.
Anesthesiology · 24d
Cleared Mar 30, 1984
RIONET HEARING AID HB-71M
K841012 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 30, 1984
TOP DISPOSABLE INFUSION SET
K841025 · FPA
Top Surgical Manufacturers Co.
General Hospital · 18d
Cleared Mar 30, 1984
REMBRANDT SHADE MODIFICATION KIT
K841111 · EBF
Den-Mat Corp.
Dental · 15d
Cleared Mar 30, 1984
NEBULO 28 NEBULIZER KIT
K841158 · BTT
Inspiron Corp.
Anesthesiology · 11d
Cleared Mar 29, 1984
DOUBLE & SINGLE TANTALUM CLIPS
K840207 · HQW
Storz Instrument Co.
Ophthalmic · 70d