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
109129–109152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 1994
BARRIER LASER PLUS FACE MASK
K934194 · FXX
Johnson & Johnson Medical, Inc.
General Hospital · 214d
Cleared Mar 28, 1994
GLOBAL MEDICAL CUTTING BIOPSY NEEDLE
K934256 · FCG
Global Medical Prods, Inc.
Gastroenterology & Urology · 209d
Cleared Mar 28, 1994
ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM
K934607 · JIX
Alko Diagnostic Corp.
Chemistry · 182d
Cleared Mar 28, 1994
MEDSURG STERILE IMAGING PRODUCTS
K934731 · FMP
Medsurg Industries, Inc.
General Hospital · 180d
Cleared Mar 28, 1994
MIDMARK MAGNUM GENERAL SURGICAL TABLE
K934744 · GDC
Midmark Corp.
General & Plastic Surgery · 175d
Cleared Mar 28, 1994
DUALGARD FACE SHIELD
K934969 · FXX
White Knight Healthcare
General Hospital · 165d
Cleared Mar 28, 1994
IL1430 BGELECTROLYTE ANALYZER
K935069 · CHL
Instrumentation Laboratory CO
Chemistry · 154d
Cleared Mar 28, 1994
UNIPOWERR RECHARGEABLE BATTERY PACK
K935111 · LDD
Unipower Corp.
Cardiovascular · 154d
Cleared Mar 28, 1994
ALPHA TALKER
K935317 · ITI
Prentke Romich Co.
Physical Medicine · 144d
Cleared Mar 28, 1994
HOVEROUND MPV
K935410 · ITI
Hoveround Corp.
Physical Medicine · 139d
Cleared Mar 28, 1994
WILSON-COOK BALLOON INFLATION DEVICE
K936168 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 95d
Cleared Mar 28, 1994
NEEDLESAFE II & NEEDLEGARD II
K936235 · FMI
Ingenious Technologies Corp.
General Hospital · 94d
Cleared Mar 28, 1994
ACTION STORM POWER WHEELCHAIR
K940051 · ITI
Invacare Corp.
Physical Medicine · 82d
Cleared Mar 28, 1994
INFUSION ADMINISTRATION SET
K940053 · FPA
Puritas Health Care, Inc.
General Hospital · 82d
Cleared Mar 28, 1994
SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)
K940258 · KPE
Incutech, Inc.
General Hospital · 66d
Cleared Mar 28, 1994
1.2 MICRON FINAL FILTER WITH EXTENSION TUBE
K940293 · FPB
Puritas Health Care, Inc.
General Hospital · 66d
Cleared Mar 28, 1994
SUPERGEL/SUPPRESSED DUST
K940402 · ELW
Harry J. Bosworth Co.
Dental · 60d
Cleared Mar 28, 1994
GLEESON FLOVAC HANDCONTROLLED SUCTION IRRIGATION INSTRUMENT
K940439 · GCJ
Conmedcorp
General & Plastic Surgery · 56d
Cleared Mar 28, 1994
LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/10
K940749 · EJH
Aalba Dent, Inc.
Dental · 38d
Cleared Mar 28, 1994
AURIUM 22KT
K940761 · EJT
Argen Precious Metals, Inc.
Dental · 38d
Cleared Mar 28, 1994
AURIUM D4
K940779 · EJT
Argen Precious Metals, Inc.
Dental · 34d
Cleared Mar 28, 1994
AURIUM B4
K940787 · EJT
Argen Precious Metals, Inc.
Dental · 34d
Cleared Mar 28, 1994
AURIUM 830
K940788 · EJT
Argen Precious Metals, Inc.
Dental · 34d
Cleared Mar 28, 1994
AURIUM SG (HIGH GOLD CROWN AND BRIDGE ALLOY)
K940855 · EJT
Argen Precious Metals, Inc.
Dental · 33d