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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
119137–119160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1991
IL TEST(TM) AMPHETAMINE
K913738 · DKZ
Instrumentation Laboratory CO
Toxicology · 79d
Cleared Nov 07, 1991
IL TEST(TM) OPIATE
K913742 · DJG
Instrumentation Laboratory CO
Toxicology · 79d
Cleared Nov 07, 1991
IL TEST(TM) PHENCYCLIDINE
K913743 · LCM
Instrumentation Laboratory CO
Toxicology · 79d
Cleared Nov 07, 1991
PATIENT EXAMINATION GLOVES
K913776 · LYY
P.T. Irama Dinamika Latex
General Hospital · 86d
Cleared Nov 07, 1991
SNOWDEN-PENCER INSUFFLATOR TUBING SET
K913835 · HIF
Snowden-Pencer
Obstetrics & Gynecology · 73d
Cleared Nov 07, 1991
OPUS(R) LH TEST SYSTEM
K913938 · CEP
Pb Diagnostic Systems, Inc.
Toxicology · 65d
Cleared Nov 07, 1991
ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS
K914066 · GEI
Laparomed Corp.
General & Plastic Surgery · 57d
Cleared Nov 07, 1991
STETHOSCOPE
K914100 · LDE
Atlas Medical Products, Inc.
Cardiovascular · 56d
Cleared Nov 07, 1991
VASCUMAP MEDICAL AIR PLETHYSMOGRAPH
K914200 · DSB
Carolina Medical Electronics
Cardiovascular · 49d
Cleared Nov 07, 1991
DENTOMAT 3 AMALGAMATORS
K914339 · EFD
Degussa AG
Dental · 41d
Cleared Nov 07, 1991
SPIKED WASHER
K914472 · HTN
Synthes (Usa)
Orthopedic · 31d
Cleared Nov 07, 1991
MODEL DLASER 1000 ND
K914568 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 23d
Cleared Nov 07, 1991
TRIGLYCERIDES REAGENT SET
K914609 · CDT
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Nov 07, 1991
PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF
K914628 · LYY
Medical Resources, Ltd.
General Hospital · 86d
Cleared Nov 06, 1991
AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR
K913523 · DXN
Omron Healthcare, Inc.
Cardiovascular · 90d
Cleared Nov 05, 1991
LYME-CHECK(TM) TEST KIT
K896378 · LSR
Diagnostic Technology, Inc.
Microbiology · 729d
Cleared Nov 05, 1991
INFU.DISK
K904619 · FRN
Electrochemical Drug Delivery, Inc.
General Hospital · 390d
Cleared Nov 05, 1991
Q4500 STREE TEST MONITOR
K910017 · DPS
Quinton, Inc.
Cardiovascular · 306d
Cleared Nov 05, 1991
PGK STEREOTACTIC DEVICE
K911974 · HRX
Northern Virginia Radiology and...
Orthopedic · 186d
Cleared Nov 05, 1991
ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES
K912250 · IWB
Theta Systems, Inc.
Radiology · 168d
Cleared Nov 05, 1991
ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION
K912477 · DQO
Interventional Therapeutics Corp.
Cardiovascular · 154d
Cleared Nov 05, 1991
ORTHOPANTOMOGRAPH 100
K912893 · EHD
Instrumentarium Corp.
Radiology · 127d
Cleared Nov 05, 1991
SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM
K912909 · FMZ
Air-Shields Vickers, Inc.
General Hospital · 126d
Cleared Nov 05, 1991
TORQUE FITTING
K912969 · DTL
Freedom Machine, Inc.
Cardiovascular · 120d