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
153889–153912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 1984
KC 100 M
K834285 · IYO
Elscint, Inc.
Radiology · 94d
Cleared Feb 17, 1984
SPECIMEN TRAP
K834467 · BYZ
Microvasive
General Hospital · 59d
Cleared Feb 17, 1984
RESPIRODYNE PULMONARY FUNCTION TEST
K834475 · BZG
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 59d
Cleared Feb 17, 1984
SOLUTION TRANSFER SET
K834500 · LHI
Berlex Laboratories, Inc.
General Hospital · 58d
Cleared Feb 17, 1984
PAPANICOLAOU STAIN SYS HT40
K840054 · HZJ
Sigma Chemical Co.
Hematology · 42d
Cleared Feb 17, 1984
NEUROMUSCULAR TRANSMISSION MONITOR
K840108 · KOI
Datex Division Instrumentarium Corp.
Anesthesiology · 38d
Cleared Feb 17, 1984
MACCONKEY AGAR W/TWEEN 80 & AMPICIL
K840190 · JSI
Remel Co.
Microbiology · 30d
Cleared Feb 17, 1984
CARDIOPLEGIA HEAT EXCHANGER HOLDER
K840256 · DTR
American Bentley
Cardiovascular · 25d
Cleared Feb 17, 1984
GROUP A SELECTIVE AGAR W/5% SHEEP BLOOD
K840294 · JSI
Bd Becton Dickinson Vacutainer...
Microbiology · 24d
Cleared Feb 17, 1984
RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI
K840336 · DQY
Arrow Intl., Inc.
Cardiovascular · 23d
Cleared Feb 17, 1984
SSA HIP PROSTHESIS
K840357 · JDI
Dow Corning Corp. Healthcare...
Orthopedic · 22d
Cleared Feb 17, 1984
OXYGEN ANALYZER 200
K840361 · CCL
Salter Labs
Anesthesiology · 22d
Cleared Feb 17, 1984
INSPIRATORY/EXPIRATORY MUSCLE EXERCIS
K840418 · BWF
Inspiron Corp.
Anesthesiology · 17d
Cleared Feb 17, 1984
PREMIUM DABM DISPOS. ANES. BREATH MASK
K840452 · BSJ
Ohio Medical Products
Anesthesiology · 16d
Cleared Feb 17, 1984
IMPROVED MOUTHPIECE
K840459 · BYP
Kinetix
Anesthesiology · 15d
Cleared Feb 17, 1984
NEUROMUSCULAR STIMULATOR 3105
K840467 · IPF
Medtronic Vascular
Physical Medicine · 14d
Cleared Feb 17, 1984
EMCO WHEELCHAIR
K840478 · IOR
Emco Medical Supply
Physical Medicine · 14d
Cleared Feb 14, 1984
TRIPLE LUMEN INFUSIONCATHETERS-
K834615 · JCY
Medical Components, Inc.
General & Plastic Surgery · 72d
Cleared Feb 14, 1984
VESSEL DILATOR
K840641
Aries Medical, Inc.
Cardiovascular
Cleared Feb 13, 1984
PILLOW COVER, ANTI-MICROBIAL
K832486 · KME
American Threshold Industries, Inc.
General Hospital · 203d
Cleared Feb 13, 1984
DRAW SHEET, ANTI-MICROBIAL
K832487 · KME
American Threshold Industries, Inc.
General Hospital · 203d
Cleared Feb 13, 1984
RESPIRATION MONITOR
K832999 · FLS
Litton Medical Electronics
Anesthesiology · 179d
Cleared Feb 13, 1984
CLOUTIER II FIBER METAL TOTAL KNEE
K833363 · JWH
Zimmer, Inc.
Orthopedic · 139d
Cleared Feb 13, 1984
IDS RAPID STR SYSTEM
K833654 · JTO
Innovative Diagnostic Systems, Inc.
Microbiology · 116d