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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13297–13320 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 2022
KYPHON VuE Bone Cement
K220131 · NDN
Tecres S.P.A.
Orthopedic · 90d
Cleared Apr 18, 2022
Nautilus
K220871 · JAA
Dornier Medtech America, Inc.
Radiology · 24d
Cleared Apr 17, 2022
BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free
K213408 · LZA
Meditech Gloves Sdn Bhd
General Hospital · 180d
Cleared Apr 15, 2022
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
K212377 · NUH
Ningbo Medkinetic Medical Device Co.,...
Neurology · 256d
Cleared Apr 15, 2022
Lilliput APD System
K212522 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 247d
Cleared Apr 15, 2022
aboNT SYRINGE
K212677 · FMF
Nipro Medical Corporation
General Hospital · 234d
Cleared Apr 15, 2022
ARDO Alyssa
K212773 · HGX
Ardo Medical AG
Obstetrics & Gynecology · 227d
Cleared Apr 15, 2022
mJOULE System and Accessories
K213350 · GEX
Sciton, Inc
General & Plastic Surgery · 189d
Cleared Apr 15, 2022
AI-Rad Companion Brain MR
K213706 · QIH
Siemens Healthcare GmbH
Radiology · 142d
Cleared Apr 15, 2022
RayStation 11B
K220141 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 87d
Cleared Apr 15, 2022
Mako Total Knee Application
K220459 · OLO
Mako Surgical Corp.
Orthopedic · 57d
Cleared Apr 15, 2022
XD
K220779 · LLZ
Mirada Medical, Ltd.
Radiology · 29d
Cleared Apr 15, 2022
FootHold System
K220797 · MBI
Crossroads Extremity Systems, LLC
Orthopedic · 28d
Cleared Apr 15, 2022
SURGIVISIO Device
K220946 · OWB
Ecential Robotics
Radiology · 14d
Cleared Apr 14, 2022
Coala Heart Monitor
K212163 · DPS
Coala Life AB
Cardiovascular · 276d
Cleared Apr 14, 2022
MagnetOs Flex Matrix
K213959 · MQV
Kuros Biosciences B.V
Orthopedic · 118d
Cleared Apr 14, 2022
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
K214023 · LON
bioMerieux, Inc.
Microbiology · 113d
Cleared Apr 14, 2022
Amputee Garment for use with Lympha Press Optimal Plus
K214053 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 108d
Cleared Apr 14, 2022
High Retention Attachment System
K220252 · NHA
Zest Anchors, LLC
Dental · 73d
Cleared Apr 14, 2022
Yushan X-Ray Flat Panel Detector with DROC
K220510 · MQB
Innocare Optoelectronics Corp.
Radiology · 51d
Cleared Apr 14, 2022
Disposable Medical Nitrile Examination Gloves
K220561 · LZA
Nanjing Universal Medical Equipment...
General Hospital · 45d
Cleared Apr 14, 2022
TeleScan
K220767 · LLZ
Bb Imaging
Radiology · 29d
Cleared Apr 13, 2022
Bendit21 Microcatheter
K203842 · QJP
Bend IT Technologies, Ltd.
Neurology · 468d
Cleared Apr 13, 2022
Cannulated Compression Device System
K210146 · HWC
Orthopedic Designs North America, Inc.
Orthopedic · 447d