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
154729–154752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 1983
COMFEEL PROTECTIVE RINGS
K832908 · EYF
Coloplast A/S
General & Plastic Surgery · 105d
Cleared Dec 12, 1983
MENISCAL SUTURE GUN
K832978 · GDF
Instrument Makar, Inc.
General & Plastic Surgery · 101d
Cleared Dec 12, 1983
SUCTION CATHETER TRAYS
K833059 · GBZ
Intermed, Inc.
General & Plastic Surgery · 95d
Cleared Dec 12, 1983
VANISH II
K833093 · KGO
Warner-Lambert Co.
General Hospital · 91d
Cleared Dec 12, 1983
VYDAX 525-550 & 5100 FLUOROTELOMER
K833357 · GDT
Ethicon, Inc.
General & Plastic Surgery · 75d
Cleared Dec 12, 1983
MULTI PURPOSE SYRINGE
K833435 · FMF
I M, Inc.
General Hospital · 68d
Cleared Dec 12, 1983
MEDI-MIST PORTA. COMPRESSOR DRIVEN
K833501 · BTI
Mountain Medical Equipment, Inc.
Anesthesiology · 68d
Cleared Dec 12, 1983
FLUOR-B. FRAG. DIRECT FLUORESCENT ANTI
K833612 · JSS
Petra Biomedical Products, Inc.
Microbiology · 60d
Cleared Dec 12, 1983
FLUOR-B MEL A DIRECT FLUORESCENT ANTI
K833613 · JSS
Petra Biomedical Products, Inc.
Microbiology · 60d
Cleared Dec 12, 1983
BRIGHAM TIBIAL CEMENT PRESSURIZER
K833675 · KIH
Howmedica Corp.
Orthopedic · 55d
Cleared Dec 12, 1983
CABOT ARTHROSCOPY SYSTEM
K833727 · HRX
Cabot Medical Corp.
Orthopedic · 28d
Cleared Dec 12, 1983
NON WETTING UNDERCAST PADDING
K833732 · ITG
American Medical Disposable, Inc.
Physical Medicine · 48d
Cleared Dec 12, 1983
NUTRA-TONE 500
K833808 · IPF
Applied Optic Kinetics , Ltd.
Physical Medicine · 40d
Cleared Dec 12, 1983
SUPERJET DISPOSABLE BLOOD LANCET
K833812 · FMK
Medrobe Laboratories
General & Plastic Surgery · 40d
Cleared Dec 12, 1983
CRISA
K833847 · ITY
X-Ray Tube Corp.
Radiology · 88d
Cleared Dec 12, 1983
THAYER MARTIN AGAR
K833862 · JTY
American Biomedical Corp.
Microbiology · 35d
Cleared Dec 12, 1983
ACE BROOKER BONE PLATING SYSTEM
K833865 · HRS
Buckman Co., Inc.
Orthopedic · 35d
Cleared Dec 12, 1983
BRUCELLA AGAR
K833886 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Dec 12, 1983
BRUCELLA BROTH
K833887 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Dec 12, 1983
PULSAIR I & II
K833994 · BYJ
Cryo Corp.
Anesthesiology · 21d
Cleared Dec 12, 1983
MINI OX II
K833995 · CCL
Catalyst Research Corp.
Anesthesiology · 21d
Cleared Dec 12, 1983
SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN
K834077 · CAF
Airlife, Inc.
Anesthesiology · 17d
Cleared Dec 09, 1983
PDM SILOXANE PROSTHETIC EAR
K832152 · GBI
Delaware Prosthetics, Inc.
General & Plastic Surgery · 157d
Cleared Dec 09, 1983
PDM SILOXANE PROSTHETIC NOSE
K832153 · GBI
Delaware Prosthetics, Inc.
General & Plastic Surgery · 157d