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
124657–124680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1990
MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP.
K901504 · DQA
Ivy Biomedical Systems, Inc.
Anesthesiology · 147d
Cleared Aug 23, 1990
FUKUDA DENSHI MODEL FX-3101
K901817 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 122d
Cleared Aug 23, 1990
MEGA 4 MAGNETIC RESONANCE IMAGING SYSTEM
K902044 · LNH
Instrumentarium Imaging, Inc.
Radiology · 108d
Cleared Aug 23, 1990
MODEL MSC SA02-5000 PULSE OXIMETER
K902192 · DQA
Medical Systems Corp.
Anesthesiology · 99d
Cleared Aug 23, 1990
THERAVIEW DIGITAL PORTAL IMAGING COMPUTER
K902339 · IYE
S & S Inficon, Inc.
Radiology · 91d
Cleared Aug 23, 1990
MCR4000 & MCR4000F CARDIOTOMY RESERVOIR
K902355 · DTP
Medtronic Vascular
Cardiovascular · 86d
Cleared Aug 23, 1990
DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS)
K902441 · KDD
Currie Medical Specialties, Inc.
General & Plastic Surgery · 83d
Cleared Aug 23, 1990
OSCILLOMETRIC PULSE DETECTION DEVICE
K902453 · DRS
Thomas J. Fogarty, M.D.
Cardiovascular · 83d
Cleared Aug 23, 1990
BYRD DILATOR SHEATH SET - TEFLON
K902469 · DRE
Medical Engineering and Development...
Cardiovascular · 80d
Cleared Aug 23, 1990
MORSE DT MANIFOLD
K902472 · DRS
North American Instrument Corp.
Cardiovascular · 80d
Cleared Aug 23, 1990
CARDIOVISTA
K902486 · DSH
Cardionostics, Inc.
Cardiovascular · 80d
Cleared Aug 23, 1990
LAKE MALE EXTERNAL CATHETERIZATION KIT
K902508 · FCM
Lake Medical Products, Inc.
Gastroenterology & Urology · 79d
Cleared Aug 23, 1990
MORTARA INSTRUMENT MODEL ELI 50
K902652 · DRT
Mortara Instrument, Inc.
Cardiovascular · 69d
Cleared Aug 23, 1990
COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC
K902758 · DQA
Cobe Laboratories, Inc.
Anesthesiology · 59d
Cleared Aug 23, 1990
A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.
K902889 · DTD
Biotronik, GmbH & Co.
Cardiovascular · 52d
Cleared Aug 23, 1990
TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE)
K902933 · LNH
General Electric Co.
Radiology · 51d
Cleared Aug 23, 1990
OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)
K902954 · HFC
Permobil AB
Obstetrics & Gynecology · 49d
Cleared Aug 23, 1990
IL THYROXINE (T4) ASSAY SYSTEM
K903095 · KLI
Instrumentation Laboratory CO
Chemistry · 41d
Cleared Aug 23, 1990
IMX B12
K903218 · LIG
Abbott Laboratories
Chemistry · 31d
Cleared Aug 23, 1990
PROLAX DISPOSABLE LATEX GLOVES (EXAM) HYPOALLERGEN
K903350 · LYY
Prolax Medical Products, Inc.
General Hospital · 29d
Cleared Aug 23, 1990
PROLAX DISPOSABLE LATEX GLOVES (EXAMINATION)
K903352 · LYY
Prolax Medical Products, Inc.
General Hospital · 28d
Cleared Aug 23, 1990
LIQUICHEK CK/LD ISOENZYME CONTROL
K903430 · JJT
Bio-Rad
Chemistry · 23d
Cleared Aug 23, 1990
ARIES TAPERSEAL(TM) SHEATH
K903442 · DYB
Aries Medical, Inc.
Cardiovascular · 23d
Cleared Aug 22, 1990
STEAMLINE
K895910 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 316d