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
140905–140928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 1987
A-BEC 17
K865008 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 47
K865009 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM
K865021 · JTA
Bd Becton Dickinson Vacutainer...
Microbiology · 45d
Cleared Feb 06, 1987
ABBOTT LIFECARE (R) 5000, PUMP SYSTEM
K865058 · FRN
Abbott Laboratories
General Hospital · 44d
Cleared Feb 06, 1987
I.V. SET W/SINGLE-CHANNEL CASSETTE
K865059 · FRN
Abbott Laboratories
General Hospital · 44d
Cleared Feb 06, 1987
I.V. SET WITH DUAL-CHANNEL CASSETTE
K865060 · FRN
Abbott Laboratories
General Hospital · 44d
Cleared Feb 06, 1987
HCI GENERAL PURPOSE CATHETER STYLET
K870014 · KGZ
Health Care Innovations, Inc.
General & Plastic Surgery · 35d
Cleared Feb 06, 1987
HCI ALL PURPOSE DRAIN/CATHETER SET
K870015 · GBS
Health Care Innovations, Inc.
General & Plastic Surgery · 35d
Cleared Feb 06, 1987
TECNOL CLASSIC CONE MASK
K870056 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 30d
Cleared Feb 06, 1987
LITHOTOMY HOLDERS
K870098 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 28d
Cleared Feb 06, 1987
PIVOTING SURGICAL ARM BOARDS
K870099
Orthopedic Systems, Inc.
General & Plastic Surgery · 28d
Cleared Feb 06, 1987
CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION
K870101 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 28d
Cleared Feb 06, 1987
RADIOLUCENT TABLE EXTENSION
K870104 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 28d
Cleared Feb 06, 1987
INFANT CAST TABLE
K870105
Orthopedic Systems, Inc.
General & Plastic Surgery · 28d
Cleared Feb 06, 1987
ALLERGEN SPECIFIC CONTROLS
K870152 · DHB
3M Company
Immunology · 24d
Cleared Feb 06, 1987
MCCUTCHEN FEMORAL HIP PROSTHESIS
K870174
Dow Corning Wright
Orthopedic · 23d
Cleared Feb 06, 1987
BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES
K870184 · FRO
Fraass Survival Systems, Inc.
General & Plastic Surgery · 21d
Cleared Feb 06, 1987
BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE)
K870185 · NAD
Fraass Survival Systems, Inc.
General & Plastic Surgery · 21d
Cleared Feb 06, 1987
MODIFIED PROFILE FEMORAL HIP
K870213
Depuy, Inc.
Orthopedic · 17d
Cleared Feb 06, 1987
FEMORAL CEMENT REMOVAL INSTRUMENTS
K870217 · HTW
Kenneth J. Hoek, M.D., Inc.
Orthopedic · 16d
Cleared Feb 06, 1987
DRESSING, BURN, 24 BY 36 INCHES
K870239 · NAD
Fraass Survival Systems, Inc.
General & Plastic Surgery · 16d
Cleared Feb 06, 1987
COMPRESS AND BANDAGE, VARIOUS SIZES
K870241 · FRO
Fraass Survival Systems, Inc.
General & Plastic Surgery · 16d
Cleared Feb 05, 1987
CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE
K862835 · EOQ
Cooper Lasersonics, Inc.
Ear, Nose, Throat · 195d
Cleared Feb 05, 1987
BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICE
K864152 · ILK
Lossing Orthopedic, Inc.
Physical Medicine · 105d