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
7249–7272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 2024
POWEReam Xia/Serrato
K240526 · NKB
Stryker Instruments
Orthopedic · 66d
Cleared Apr 29, 2024
Volnewmer™
K240248 · GEI
Classys, Inc.
General & Plastic Surgery · 90d
Cleared Apr 29, 2024
Blood Pressure Monitor (TMB-2287-B)
K240102 · DXN
Guangdong Transtek Medical...
Cardiovascular · 104d
Cleared Apr 29, 2024
ARVIS® Shoulder
K240062 · OLO
Insight Medical Systems, Inc.
Orthopedic · 111d
Cleared Apr 29, 2024
Ultraflex Esophageal NG Stent System
K233939 · ESW
Boston Scientific
Gastroenterology & Urology · 137d
Cleared Apr 29, 2024
SubtleREFORMAT (1.x)
K233699 · LLZ
Subtle Medical, Inc.
Radiology · 164d
Cleared Apr 29, 2024
Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
K232511 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 255d
Cleared Apr 26, 2024
EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
K240879 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 26, 2024
Erisma® Deformity Spinal System
K240872 · NKB
Clariance
Orthopedic · 28d
Cleared Apr 26, 2024
Reef L Interbody System
K240566 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 57d
Cleared Apr 26, 2024
Sonio Detect
K240406 · IYN
Sonio
Radiology · 77d
Cleared Apr 26, 2024
EMPOWR Revision Symmetric Knee Cones
K240324 · JWH
Encore Medical, L.P Dba Enovis
Orthopedic · 84d
Cleared Apr 26, 2024
Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)
K240299 · MBH
Zimmer, Inc.
Orthopedic · 85d
Cleared Apr 26, 2024
NB Mini Implant System
K240091 · DZE
Arum Dentistry Co., Ltd.
Dental · 105d
Cleared Apr 26, 2024
XLO Brand of Locking Distal Humerus Plating System
K233873 · HRS
Ortho Life Systems Private Limited
Orthopedic · 141d
Cleared Apr 26, 2024
Bone Anchor (NGS-BA-01)
K233703 · HAW
ClearPoint Neuro, Inc.
Neurology · 161d
Cleared Apr 26, 2024
uMR Jupiter
K233673 · LNH
Shanghai United Imaging Healthcare...
Radiology · 162d
Cleared Apr 26, 2024
FCT iSTREAM Phase 1
K233583 · JAK
Fujifilm Healthcare Americas Corporation
Radiology · 171d
Cleared Apr 26, 2024
syngo.via RT Image Suite
K232799 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 227d
Cleared Apr 26, 2024
Rhinolaryngoscope system
K232435 · EOB
Shenzhen HugeMed Medical Technical...
Ear, Nose, Throat · 256d
Cleared Apr 26, 2024
UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA...
K232317 · JIO
Urit Medical Electronic Co., Ltd.
Chemistry · 267d
Cleared Apr 26, 2024
Pocket III
K232302 · IYO
Quantel Medical
Radiology · 269d
Cleared Apr 26, 2024
DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
K232298 · OWB
Canon, Inc.
Radiology · 269d
Cleared Apr 26, 2024
TME Temporary Myocardial Electrode
K232261 · LDF
Osypka AG
Cardiovascular · 270d