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
153073–153096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1984
RUBAQUICK DIAGNOSTIC KIT
K834032 · GOL
Abbott Laboratories
Hematology · 147d
Cleared Apr 17, 1984
SARNS 8.0 SOFT ARC CANNULA
K834134 · DWF
3M Health Care, Sarns
Cardiovascular · 139d
Cleared Apr 17, 1984
HOLTER CARDIOGRAPHY SYS 6201
K834397 · DSI
Instruments For Cardiac Research
Cardiovascular · 125d
Cleared Apr 17, 1984
ALPHA MASS STORAGE CARDULE 1895
K834597 · DSI
Spacelabs, Inc.
Cardiovascular · 109d
Cleared Apr 17, 1984
MICROFUSE INTRAVENOUS CATHETER SET
K840240 · DQY
Norton Performance Plastics Corp.
Cardiovascular · 88d
Cleared Apr 17, 1984
MINI-DEFIBRILLATOR 280/4
K840246 · LDD
Life Science Instrumentation, Inc.
Cardiovascular · 96d
Cleared Apr 17, 1984
CARDIOFAX ECG 6543
K840274 · DRS
Nihon Kohden America, Inc.
Cardiovascular · 85d
Cleared Apr 17, 1984
ANGIOGRAPHIC DRAPE PACKS
K840281 · DXT
Medrad, Inc.
Cardiovascular · 85d
Cleared Apr 17, 1984
MCA IN THE EAR CUSTOM HEARING AID
K840298 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 84d
Cleared Apr 17, 1984
HAEMOPHILUS I.D. II TRIPLATE
K840338 · JSI
Remel Co.
Microbiology · 83d
Cleared Apr 17, 1984
RETROGRADE INFUSION SET 3ML & 6ML-
K840443 · FPA
Tico Medical Instruments, Inc.
General Hospital · 76d
Cleared Apr 17, 1984
SHILEY PREBYPASS FILTER
K840450 · KRJ
Shiley, Inc.
Cardiovascular · 76d
Cleared Apr 17, 1984
BIOTIS ABNORMAL CLINICAL CHEM SERUM-
K840458 · JJY
Otisville Biotech, Inc.
Microbiology · 75d
Cleared Apr 17, 1984
FLUID REMOVAL ASSEMBLY
K840490 · FMF
Ackrad Laboratories
General Hospital · 71d
Cleared Apr 17, 1984
RESIL
K840548 · EBI
Parker Laboratories, Inc.
Dental · 69d
Cleared Apr 17, 1984
NEONATAL PHYSIOLOGICAL MONITOR 903
K840560 · DRT
Novametrix Medical Systems, Inc.
Cardiovascular · 69d
Cleared Apr 17, 1984
PEDIATRIC ARTERIAL BLOOD FILTER
K840612 · DTM
American Bentley
Cardiovascular · 64d
Cleared Apr 17, 1984
HARRIS-GALANTE POROUS TOTAL HIP SYS
K840643 · JDI
Zimmer, Inc.
Orthopedic · 62d
Cleared Apr 17, 1984
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
K840658 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 62d
Cleared Apr 17, 1984
COR-TEMP-TEMP. MONITOR
K840675 · FLL
Product Research Organizations,Inc.
General Hospital · 62d
Cleared Apr 17, 1984
PORPHYRIN TEST AGAR
K840685 · JSF
Remel Co.
Microbiology · 62d
Cleared Apr 17, 1984
CIRCUIT BREATHING
K840740 · CAI
Marquest Medical Products, Inc.
Anesthesiology · 60d
Cleared Apr 17, 1984
GAST STAT MONITORING SYSTEM
K840749 · DTY
Cardiovascular Devices, Inc.
Cardiovascular · 54d
Cleared Apr 17, 1984
HAEMOFUGE A. BIOFUGE A. & B
K840767 · JPI
Heraeus-Christ GmbH
Hematology · 54d