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
21121–21144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 2019
ROSA ONE Spine application
K192173 · OLO
Medtech S.A
Orthopedic · 78d
Cleared Oct 29, 2019
PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
K192369 · LCP
Ixensor Co, Ltd.
Chemistry · 60d
Cleared Oct 29, 2019
NexGen Anterior Cervical Plate System
K192494 · KWQ
Precision Spine
Orthopedic · 48d
Cleared Oct 28, 2019
3d Cage
K180347 · MAX
Fims Co., Ltd.
Orthopedic · 627d
Cleared Oct 28, 2019
HS AMICA devices family
K182605 · GEI
H.S Hospital Service S.P.A
General & Plastic Surgery · 402d
Cleared Oct 28, 2019
KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
K191881 · LEJ
Kbl GmbH
General & Plastic Surgery · 105d
Cleared Oct 28, 2019
Straumann PUREloc abutments
K192029 · NHA
Institut Straumann AG
Dental · 90d
Cleared Oct 28, 2019
LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
K192046 · QFO
DiaSorin, Inc.
Microbiology · 89d
Cleared Oct 28, 2019
3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
K192673 · JOJ
3M Company
General Hospital · 32d
Cleared Oct 28, 2019
primeMidline Catheters
K192802 · PND
Pfm Medical, Inc.
General Hospital · 28d
Cleared Oct 27, 2019
EarlyVue VS30
K190624 · DSJ
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 230d
Cleared Oct 25, 2019
Instruments for LINK MEGASYSTEM-C Family
K190181 · KRO
LinkBio Corp.
Orthopedic · 266d
Cleared Oct 25, 2019
IOB Warming Blankets
K190221 · DWJ
Iob Medical, Inc.
Cardiovascular · 262d
Cleared Oct 25, 2019
REDAPT Blade Augments
K190847 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Oct 25, 2019
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
K191007 · IYN
Supersonic Imagine
Radiology · 192d
Cleared Oct 25, 2019
Maverick RNP Assay and Maverick Diagnostic System
K191085 · LKO
Genalyte, Inc.
Immunology · 184d
Cleared Oct 25, 2019
C-CAT Anaesthesia Catheter kit
K191470 · BSO
Cimpax Aps
Anesthesiology · 144d
Cleared Oct 25, 2019
FILTRAY 2G Disposable Water Filters
K191563 · NHV
Aqua-Tools
Gastroenterology & Urology · 134d
Cleared Oct 25, 2019
ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
K191807 · NXO
ALPCO
Immunology · 112d
Cleared Oct 25, 2019
F5 Corpus VS
K191874 · IPL
Permobil AB
Physical Medicine · 105d
Cleared Oct 25, 2019
IntellaMap Orion High Resolution Mapping Catheter
K192360 · DRF
Boston Scientific Corporation
Cardiovascular · 56d
Cleared Oct 25, 2019
Reusable Monopolar Active Cord
K192518 · GEI
Us Endoscopy
General & Plastic Surgery · 42d
Cleared Oct 25, 2019
gel-e Flex+ gel OTC
K192667 · QSY
Gel-E, Inc.
General & Plastic Surgery · 30d
Cleared Oct 25, 2019
MiniCap Extended Life PD Transfer Sets
K192705 · KDJ
Baxter Healthcare
Gastroenterology & Urology · 28d