FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37537–37560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2014
ANS1 SOFTWARE
K140412 · DXN
Ld Technology, LLC
Cardiovascular · 93d
Cleared May 22, 2014
ANTHRACIS REAL-TIME PCR ASSAY
K140426 · NHT
Centers For Disease Control and...
Microbiology · 92d
Cleared May 22, 2014
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
K140454 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared May 22, 2014
CAPTIA MEASLES IGM
K140455 · PCL
Trinity Biotech USA
Microbiology · 87d
Cleared May 22, 2014
RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND...
K140522 · JJY
Randox Laboratories Limited
Chemistry · 79d
Cleared May 22, 2014
EVEREST SPINAL SYSTEM
K140529 · NKB
K2m, LLC
Orthopedic · 79d
Cleared May 22, 2014
SALVATION 3DI PLATING SYSTEM
K140792 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 52d
Cleared May 22, 2014
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
K141220 · NSU
Thermo Fisher Scientific (Life...
Microbiology · 10d
Cleared May 21, 2014
DOUBLE ENGINE INTRAMEDDULLARY NAIL SYSTEM
K131609 · HSB
Xiamen Double Engine Medical Material...
Orthopedic · 352d
Cleared May 21, 2014
SOLUM IV BONE VOID FILLER
K132470 · MQV
Spinesmith Partners, Llp
Orthopedic · 287d
Cleared May 21, 2014
MOTEX POWDERED NITRILE SURGICAL GLOVES
K132802 · KGO
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 257d
Cleared May 21, 2014
HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)
K132937 · EBG
Harvest Dental Products, LLC
Dental · 245d
Cleared May 21, 2014
MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
K133428 · BZG
Medikro OY
Anesthesiology · 194d
Cleared May 21, 2014
SILC FIXATION SYSTEM
K133482 · OWI
Globus Medical, Inc.
Orthopedic · 189d
Cleared May 21, 2014
CARDIOHELP SYSTEM
K133598 · DTQ
Maquet Cardiopulmonary, AG
Cardiovascular · 180d
Cleared May 21, 2014
NOVOFINE PLUS 32G 4 MM
K133738 · FMI
Novo Nordisk, Inc.
General Hospital · 163d
Cleared May 21, 2014
NO TOUCH+FOREHEAD NTF 3000 THERMOMETER
K134043 · FLL
Kaz USA, Inc (A Subsidiaryof Kaz Inc)
General Hospital · 141d
Cleared May 21, 2014
HYGEDENT ALGINATE IMPRESSION MATERIAL
K140074 · ELW
Hygedent, Inc.
Dental · 128d
Cleared May 21, 2014
SPRINGTMS TOTAL MIGRAINE SYSTEM
K140094 · OKP
Eneura Therapeutics, LLC
Neurology · 127d
Cleared May 21, 2014
EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
K140151 · QEY
Btg International, Inc.
Cardiovascular · 119d
Cleared May 21, 2014
VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM
K140169 · LJT
Cook Incorporated
General Hospital · 118d
Cleared May 21, 2014
SKINTACT
K140340 · GXY
Leonhard Lang GmbH
Neurology · 99d
Cleared May 21, 2014
GALAFLEX MESH
K140533 · OOD
Tepha, Inc.
General & Plastic Surgery · 78d
Cleared May 21, 2014
TRINICA ANTERIOR LUMBAR PLATE SYSTEM
K140611 · KWQ
Zimmer Spine, Inc.
Orthopedic · 72d