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
128329–128352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 1989
ULTRACOMPACT
K894968 · EXY
Eutectic Electronics, Inc.
Gastroenterology & Urology · 93d
Cleared Nov 08, 1989
DAVOL ARTHROSCOPY CANNULA
K894990 · HRX
Davol, Inc.
Orthopedic · 92d
Cleared Nov 08, 1989
COMA COCAINE METABOLITE ASSAY (EIA)
K895043 · DIO
Serex, Inc.
Toxicology · 91d
Cleared Nov 08, 1989
NF-1 MINDPEACE
K895175 · QJQ
Neurofitness
Neurology · 90d
Cleared Nov 08, 1989
FIAGEN T3 UPTAKE CATALOGUE #101-402
K895186 · KHQ
Cyberfluor, Inc.
Chemistry · 89d
Cleared Nov 08, 1989
THE ON-GARD RECAPPER
K895220 · FMF
On-Gard Systems, Inc.
General Hospital · 84d
Cleared Nov 08, 1989
LASERMATIC COMBOLASER MODEL 5050
K895279 · GEX
Lasermatic OY
General & Plastic Surgery · 76d
Cleared Nov 08, 1989
TRANSDUCER PROTECTOR
K895281 · FIB
Filtertek, Inc.
Gastroenterology & Urology · 76d
Cleared Nov 08, 1989
HDL SINGLES
K895381 · LBR
Trace America, Inc.
Chemistry · 71d
Cleared Nov 08, 1989
LATEX EXAMINATION GLOVES
K895552 · LYY
Jung Hua Co.
General Hospital · 56d
Cleared Nov 08, 1989
HUMAN (IGG) SUBCLASS (EIA) KIT
K895600 · DAS
The Binding Site, Ltd.
Immunology · 51d
Cleared Nov 08, 1989
DAILY ACTIVITY ASSIST DEVICE (MOBILE STANDING AID)
K895686 · IPL
Stand-N-Go Corp.
Physical Medicine · 47d
Cleared Nov 08, 1989
THE DOCTOR'S CHOICE ELECTRODE
K895737 · GEI
The Skin Care Centre
General & Plastic Surgery · 43d
Cleared Nov 08, 1989
HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H
K895759 · KDI
National Medical Care, Medical...
Gastroenterology & Urology · 43d
Cleared Nov 08, 1989
ASNIS II GUIDED BONE SCREW
K895766 · HWC
Howmedica Corp.
Orthopedic · 43d
Cleared Nov 08, 1989
SHANNON LATEX MEDICAL GLOVES
K895804 · LYY
Cashmor Mfg. , Ltd.
General Hospital · 41d
Cleared Nov 08, 1989
ONE TOUCH II METER
K895911 · CGA
Lifescan, Inc.
Chemistry · 29d
Cleared Nov 08, 1989
WAKO(TM) AUTOKIT GAMMA-GT
K895984 · JPZ
Wako Chemicals USA, Inc.
Chemistry · 26d
Cleared Nov 08, 1989
CEDIA DIGITOXIN ASSAY
K896021 · LFM
Microgenics Corp.
Toxicology · 23d
Cleared Nov 08, 1989
SURGI-BRUSH
K896085 · GEC
Sparta Surgical Corp.
General & Plastic Surgery · 20d
Cleared Nov 08, 1989
REFLUX BED
K896256 · INW
Cozcon, Inc.
Physical Medicine · 8d
Cleared Nov 08, 1989
QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)
K896271 · DHR
Biokit USA, Inc.
Immunology · 9d
Cleared Nov 08, 1989
QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL
K896272 · DCN
Biokit USA, Inc.
Immunology · 9d
Cleared Nov 08, 1989
SURGEON'S GLOVES
K896327 · KGO
Productes Del Latex, S.A.
General Hospital · 6d