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
133993–134016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1988
PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)
K882879 · DXC
Pioneering Technologies, Inc.
Cardiovascular · 63d
Cleared Sep 12, 1988
MX860, REUSABLE PRESSURE TRANSDUCER
K883095 · DRS
Medex, Inc.
Cardiovascular · 52d
Cleared Sep 12, 1988
MULTINEX MONITOR (MODIFICATION)
K883254 · CCL
Datascope Corp.
Anesthesiology · 41d
Cleared Sep 12, 1988
HEARTSTART 1000
K883341 · MKJ
Laerdal Mfg. Corp.
Cardiovascular · 34d
Cleared Sep 12, 1988
HEARTSTART 1000S
K883344 · MKJ
Laerdal Mfg. Corp.
Cardiovascular · 34d
Cleared Sep 12, 1988
RAYMAX 2100 MODELS 2130 & 2136
K883431 · IZO
Raymax Medical Corp.
Radiology · 28d
Cleared Sep 12, 1988
MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE
K883575 · HMG
Site Microsurgical Systems, Inc.
Ophthalmic · 21d
Cleared Sep 09, 1988
URINE TOXICOLOGY STANDARD
K881320 · DKB
Verichem Laboratories, Inc.
Toxicology · 165d
Cleared Sep 09, 1988
PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
K881616 · JXG
Progress Mankind Technology
Neurology · 150d
Cleared Sep 09, 1988
BIODYNAMICS AUTOTRANSFUSION RESERVOIR
K881631 · CAC
Biodynamics Corp.
Anesthesiology · 148d
Cleared Sep 09, 1988
PREGNAGEN(TM)
K882002 · JHI
Biogenex Laboratories
Chemistry · 119d
Cleared Sep 09, 1988
MINIM-X 2001-CIAS & MINIM-X 2002-CIAS
K882379 · EAP
Dentomar, Inc.
Radiology · 92d
Cleared Sep 09, 1988
OPHTHALMIC FLUID INJECTOR
K882403 · FMF
Trek Medical Products, Inc.
General Hospital · 91d
Cleared Sep 09, 1988
MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0
K882506 · KMJ
Span-America Medical Systems, Inc.
General Hospital · 92d
Cleared Sep 09, 1988
OPHTHALMIC PAO VALVE
K882536 · FMF
Look, Inc.
General Hospital · 80d
Cleared Sep 09, 1988
GESCO CATHETERIZATION TRAY
K882647 · GBQ
Gesco Intl., Inc.
General & Plastic Surgery · 74d
Cleared Sep 09, 1988
KTP/YAG(TM) SURGICAL LASER
K882734 · GEX
Laserscope
General & Plastic Surgery · 70d
Cleared Sep 09, 1988
MODEL AU-1 ACCESSORY UNIT
K882926 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 58d
Cleared Sep 09, 1988
STAT FAX(TM)
K882938 · JJQ
Awareness Technology, Inc.
Chemistry · 58d
Cleared Sep 09, 1988
BLOOD GAS MIXTURE
K882941 · CHL
Swisco, Inc.
Chemistry · 64d
Cleared Sep 09, 1988
A.QC CHEMISTRY CONTROL LEVEL 2
K883012 · JJY
Arden Medical Systems, Inc.
Chemistry · 52d
Cleared Sep 09, 1988
T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS
K883085 · KHQ
Serono Diagnostics, Inc.
Chemistry · 49d
Cleared Sep 09, 1988
DADE TDM CONTROL
K883190 · DIF
Baxter Healthcare Corp
Pathology · 43d
Cleared Sep 09, 1988
ALTLTS ALANINE AMINO TRANSFERASE ALT
K883205 · CKA
Electro-Nucleonics, Inc.
Chemistry · 43d