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
38353–38376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2014
T-TYPE D-KAT, R-TYPE D-KAT
K133234 · HKY
Keeler Limited
Ophthalmic · 123d
Cleared Feb 21, 2014
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
K133409 · MQB
Rayence Co., Ltd.
Radiology · 106d
Cleared Feb 21, 2014
SHERPA PAK CARDIAC TRANSPORT SYSTEM
K133432 · MSB
Paragonix Technologies, Inc.
Gastroenterology & Urology · 108d
Cleared Feb 21, 2014
ADVIA CENTAUR TESTOSTERONE (TSTO)
K133491 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 100d
Cleared Feb 21, 2014
EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE...
K133509 · NBW
Biotest Medical Corp.
Chemistry · 99d
Cleared Feb 21, 2014
MONITOR B40
K133576 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 93d
Cleared Feb 21, 2014
LZI MULTIPLE ANALYTE SET A
K133710 · DKB
Lin-Zhi International, Inc.
Toxicology · 79d
Cleared Feb 21, 2014
BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R)...
K133948 · KNW
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 60d
Cleared Feb 20, 2014
ADVANCED PERFUSION SYSTEM 1
K131041 · DTQ
Terumo Cardiovascular Systems Corp.
Cardiovascular · 311d
Cleared Feb 20, 2014
PROINSERT
K131145 · MQK
Nidacon International AB
Obstetrics & Gynecology · 303d
Cleared Feb 20, 2014
INFANT PHOTOTHERAPY BILITRON SKY 5006
K131196 · LBI
Fanem Lda
General Hospital · 300d
Cleared Feb 20, 2014
CANTATA(R) 2.9 MICROCATHETER
K131772 · KRA
Cook, Inc.
Cardiovascular · 248d
Cleared Feb 20, 2014
JMS SYRINGE
K132321 · FMF
JMS North America Corporation
General Hospital · 210d
Cleared Feb 20, 2014
PELLEFIRM
K132949 · PBX
Ellman International, Inc.
General & Plastic Surgery · 154d
Cleared Feb 20, 2014
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
K133076 · OCY
Neometrics, Inc.
Gastroenterology & Urology · 143d
Cleared Feb 20, 2014
UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K133567 · KWQ
Globus Medical, Inc.
Orthopedic · 92d
Cleared Feb 20, 2014
INBONE TOTAL ANKLE
K133585 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 91d
Cleared Feb 20, 2014
JAZZ SYSTEM
K133617 · OWI
Implanet, S.A.
Orthopedic · 87d
Cleared Feb 20, 2014
RELIEVA SCOUT SINUS DILATION SYSTEM
K140160 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 29d
Cleared Feb 19, 2014
RS-3000 ADVANCE
K132323 · OBO
Nidek Co., Ltd.
Ophthalmic · 209d
Cleared Feb 19, 2014
MEDICINAL LEECHES
K132958 · NRN
North America BioPharma
General & Plastic Surgery · 152d
Cleared Feb 19, 2014
MODIFICATION TO NAUTILUS SPINAL SYSTEM
K133564 · NKB
Life Spine, LLC
Orthopedic · 91d
Cleared Feb 19, 2014
8MM TROCAR KIT
K133845 · GCJ
Intuitive Surgical
General & Plastic Surgery · 63d
Cleared Feb 19, 2014
DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM
K140030 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 44d