FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
133273–133296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1989
ESP 3-PHASE X-RAY GENERATORS
K884678 · IZO
Elscint, Inc.
Radiology · 70d
Cleared Jan 17, 1989
FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884707 · LCS
Cyberfluor, Inc.
Chemistry · 69d
Cleared Jan 17, 1989
FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT
K884708 · CGJ
Cyberfluor, Inc.
Chemistry · 69d
Cleared Jan 17, 1989
SHILEY PERC TRACHEOSTOMY SYSTEM
K884730 · BTO
Shiley, Inc.
Anesthesiology · 68d
Cleared Jan 17, 1989
MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY
K884769 · CEM
Ciba Corning Diagnostics Corp.
Chemistry · 64d
Cleared Jan 17, 1989
MODEL 3587A RESUME EPIDURAL LEAD
K884948 · GZB
Medtronic Vascular
Neurology · 53d
Cleared Jan 17, 1989
FR6000 FLOWMETER
K884973 · CAX
Key Instruments
Anesthesiology · 48d
Cleared Jan 17, 1989
MAGNESIUM TEST ITEM NUMBER: SR1019
K885022 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 17, 1989
MODEL 3487A PISCES EPIDURAL LEAD
K885033 · GZB
Medtronic Vascular
Neurology · 43d
Cleared Jan 17, 1989
HPD STERILE HUMIDIFYING CHAMBER
K885314 · BTT
Hpd Medical, Inc.
Anesthesiology · 19d
Cleared Jan 13, 1989
PROMO-RIST C.P.M.
K881314 · BXB
Professional Motion, Inc.
Physical Medicine · 291d
Cleared Jan 13, 1989
ELECTR-TRANSBLOTTER
K882344 · JJN
The W.E.P. Co.
Chemistry · 220d
Cleared Jan 13, 1989
ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID
K882633 · ESD
Ensoniq Corp.
Ear, Nose, Throat · 200d
Cleared Jan 13, 1989
STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT
K883373 · DZE
Denar Corp.
Dental · 157d
Cleared Jan 13, 1989
LYME FAST TEST
K883544 · LSR
3M Company
Microbiology · 147d
Cleared Jan 13, 1989
BUCKET PROSTHESIS PORP
K883727 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 135d
Cleared Jan 13, 1989
VENTRALITH I
K883750 · DXY
Bio Pace Technology, Inc.
Cardiovascular · 134d
Cleared Jan 13, 1989
PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT
K884421 · DXQ
Pymah Corp.
Cardiovascular · 85d
Cleared Jan 13, 1989
FITC MURINE MONOCLONAL ANTI-RSV IGG
K884516 · GQG
Whittaker Bioproducts, Inc.
Microbiology · 78d
Cleared Jan 13, 1989
FIRSTDAY EARLY PREGNANCY TESTING KIT II
K884616 · JHI
Pacific Biotech, Inc.
Chemistry · 70d
Cleared Jan 13, 1989
ACUSON I5100 ULTRASOUND TRANSDUCER
K884632 · IYO
Acuson Corp.
Radiology · 67d
Cleared Jan 13, 1989
CLINISTAT GLUCOSE REAGENT TEST
K884756 · CGA
Heraeus Kulzer, Inc.
Chemistry · 60d
Cleared Jan 13, 1989
PREGNAGEN(TM)
K884880 · JHI
Biogenex Laboratories
Chemistry · 53d
Cleared Jan 13, 1989
SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER
K884900 · KNW
Siemens Medical Solutions USA, Inc.
Gastroenterology & Urology · 51d