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
136561–136584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1988
MARLEN ULTRA ILEOSTOMY POUCH-5000
K880327 · EZQ
Marlen Mfg. & Development Co.
Gastroenterology & Urology · 24d
Cleared Feb 19, 1988
KIMBERLY-CLARK PROFESSIONAL JACKET
K880385 · FME
Kimberly-Clark Corp.
General Hospital · 22d
Cleared Feb 19, 1988
TRACK AND CARRIER, INTRAVENOUS
K880538 · FOX
Ferguson Medical
General Hospital · 10d
Cleared Feb 18, 1988
COXA ACETABULAR CUP
K871852 · JDI
Thackray USA
Orthopedic · 282d
Cleared Feb 18, 1988
PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM
K871912 · DPT
Electro-Diagnostic Instruments
Cardiovascular · 276d
Cleared Feb 18, 1988
DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT
K872632 · GQN
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 227d
Cleared Feb 18, 1988
GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN
K873032 · DXK
Biosound, Inc.
Cardiovascular · 198d
Cleared Feb 18, 1988
DSL ACTIVE ESTRADIOL RIA (DSL #4300)
K873550 · CHP
Diagnostic Systems Laboratories, Inc.
Chemistry · 171d
Cleared Feb 18, 1988
SERIES 77000 ULTRASOUND IMAGING SYSTEM
K873762 · DXK
Hewlett-Packard Co.
Cardiovascular · 155d
Cleared Feb 18, 1988
AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144
K874362 · KHQ
Amersham Corp.
Chemistry · 118d
Cleared Feb 18, 1988
DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER
K874442 · DQA
Critikon Company, LLC
Anesthesiology · 113d
Cleared Feb 18, 1988
GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM.
K874500 · EMA
Harry J. Bosworth Co.
Dental · 108d
Cleared Feb 18, 1988
PRECEPT(TM) CIPROFLOXACIN
K874727 · JWY
Austin Biological Laboratories
Microbiology · 92d
Cleared Feb 18, 1988
LYPHOCHEK WHOLE BLOOD CONTROL
K874731 · JJY
Bio-Rad
Chemistry · 92d
Cleared Feb 18, 1988
CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER
K874763 · GKZ
Instrumentation Laboratory CO
Hematology · 91d
Cleared Feb 18, 1988
COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5
K874808 · DJG
Diagnostic Products Corp.
Toxicology · 87d
Cleared Feb 18, 1988
ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP
K874874 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Feb 18, 1988
ACROMED CROSS ROD CONNECTOR
K874882 · KWP
Acromed Corp.
Orthopedic · 79d
Cleared Feb 18, 1988
CANYON MEDICAL FEMORAL BYPASS CANNULAE
K874899 · DWF
Canyon Medical Products
Cardiovascular · 79d
Cleared Feb 18, 1988
SUN MEDICAL SMOKE EVACUATOR SYSTEM
K874948 · GEX
Sun Medical, Inc.
General & Plastic Surgery · 78d
Cleared Feb 18, 1988
SARNS VENOATRIAL CATHETER
K875048 · DWF
3M Health Care, Sarns
Cardiovascular · 71d
Cleared Feb 18, 1988
ASPARTATE AMINOTRANSFERASE AST/SGOT
K875071 · CIT
Tech-Co, Inc.
Chemistry · 71d
Cleared Feb 18, 1988
STERI-CLENS
K875129 · GEC
Absorbent Cotton Co., Inc.
General & Plastic Surgery · 65d
Cleared Feb 18, 1988
THIELER KIT
K875153 · KKX
Taris Corp.
General Hospital · 65d