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
154369–154392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1984
THIO W/SUPPLEMENT
K834321 · JSG
Hardy Media
Microbiology · 35d
Cleared Jan 13, 1984
EMMON 3 SABDEX
K834322 · JSG
Hardy Media
Microbiology · 35d
Cleared Jan 13, 1984
POTATO DEXTROSE AGAR
K834323 · JSG
Hardy Media
Microbiology · 35d
Cleared Jan 13, 1984
INHIBITORY MOLD AGAR
K834325 · JSJ
Hardy Media
Microbiology · 35d
Cleared Jan 13, 1984
CIN AGAR
K834327 · JSF
Hardy Media
Microbiology · 35d
Cleared Jan 13, 1984
3-D PASSIVE MOBILIZER
K834360 · ISD
3-D Orthopedic, Inc.
Physical Medicine · 31d
Cleared Jan 13, 1984
FLYNN III-CHILD BAG-MASK UNIT ETC
K834400 · BTM
O-Two Systems Intl., Inc.
Anesthesiology · 30d
Cleared Jan 13, 1984
TEC TRACTION MACHINE
K834405 · ITH
Akron Medical Corp.
Physical Medicine · 30d
Cleared Jan 13, 1984
PRESERV PVA FIXATIVE 15ML-FORMALIN PK
K834412 · KDT
Preventive Diagnostics Corp.
Microbiology · 29d
Cleared Jan 13, 1984
HELENA BIO STRIP OB
K834456 · KHE
Helena Laboratories
Chemistry · 25d
Cleared Jan 13, 1984
LARYNGOTRACHEAL TOPICAL ANES. APPLI
K834463
Sheridan Catheter Corp.
Cardiovascular · 24d
Cleared Jan 13, 1984
DESERET EPIDURAL CATHETER
K834472
Parke-Davis Co.
Cardiovascular · 24d
Cleared Jan 12, 1984
SYVA ADVANCE DIGOXIN ASSAY
K833791 · KXT
Syva Co.
Toxicology · 73d
Cleared Jan 12, 1984
CAMPY 5H
K834326 · JSJ
Hardy Media
Microbiology · 34d
Cleared Jan 11, 1984
RESPICOMB
K823783 · BZK
Respitrace Corp.
Anesthesiology · 392d
Cleared Jan 11, 1984
MEDICAL EXAM TABLE
K830294 · LGX
Coe Laboratories, Inc.
General Hospital · 349d
Cleared Jan 11, 1984
LIFE VAC #2191 & 2192
K831802 · LJS
Exco, Inc.
General Hospital · 222d
Cleared Jan 11, 1984
HOSPITAL LAB IN-HOME EARLY PREG TEST
K832593 · LCX
Aicl-Pack, Inc.
Chemistry · 162d
Cleared Jan 11, 1984
DIRIA-PROGK IMMUNOASSAY
K832694 · JLS
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 154d
Cleared Jan 11, 1984
CHEM TRAK LIQUID BILIRUBIN CONTROL
K833097 · JJX
Medical Analysis Systems, Inc.
Chemistry · 121d
Cleared Jan 11, 1984
AZLOCILLIN 75MCG. SENSITIVITY DISCS
K833414 · JTN
Difco Laboratories, Inc.
Microbiology · 100d
Cleared Jan 11, 1984
TICARCILLIN 75MCG. SENSITIVITY DISCS
K833415 · JTN
Difco Laboratories, Inc.
Microbiology · 100d
Cleared Jan 11, 1984
CEFTIZOXIME 30 MCG SENSITIVITY DISCS
K833416 · JTN
Difco Laboratories, Inc.
Microbiology · 100d
Cleared Jan 11, 1984
ADRENOCOR TICOTROPIC HORMONE RADIOIMM
K833471 · CKG
Nichols Institute Diagnostics
Chemistry · 97d