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
9169–9192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2023
Catalyst R1 Reverse Shoulder System
K232583 · PHX
Catalyst Orthoscience, Inc.
Orthopedic · 26d
Cleared Sep 20, 2023
Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
K232582 · EOQ
Ambu A/S
Ear, Nose, Throat · 26d
Cleared Sep 20, 2023
DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular...
K232556 · LPH
Depuy Ireland UC
Orthopedic · 28d
Cleared Sep 20, 2023
LED Spectrum therapy instrument
K231894 · GEX
Shenzhenshi Sincoheren S&T...
General & Plastic Surgery · 84d
Cleared Sep 20, 2023
1788 4K Camera System with Advanced Imaging Modality
K231854 · OWN
Stryker
General & Plastic Surgery · 89d
Cleared Sep 20, 2023
Rology Teleradiology Platform (v.1.22.1103)
K231385 · LLZ
Rology, Inc.
Radiology · 131d
Cleared Sep 20, 2023
Insufflator (OPTO-IFL1000)
K231342 · HIF
Guangdong Optomedic Technologies, Inc.
Obstetrics & Gynecology · 134d
Cleared Sep 20, 2023
TULSA-PRO System
K230692 · PLP
Profound Medical, Inc.
Gastroenterology & Urology · 191d
Cleared Sep 20, 2023
AirSeal iFS System
K230239 · HIF
Conmed Corporation
Obstetrics & Gynecology · 233d
Cleared Sep 20, 2023
Insulin Pen Needle
K230043 · FMI
Anhui Hongyu Wuzhou Medical...
General Hospital · 257d
Cleared Sep 20, 2023
Mpact Extension
K230011 · LPH
Medacta International S.A.
Orthopedic · 260d
Cleared Sep 20, 2023
Socrates Aspiration System
K223913 · NRY
Scientia Vascular, Inc.
Neurology · 265d
Cleared Sep 20, 2023
MedCAD AccuPlan Orthopedics System
K223421 · PBF
Medcad
Orthopedic · 314d
Cleared Sep 20, 2023
Cholestech LDX ™ System
K223179 · CGA
Alere San Diego, Inc.
Chemistry · 344d
Cleared Sep 20, 2023
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG...
K213987 · MXJ
Biokit, S.A.
Microbiology · 639d
Cleared Sep 19, 2023
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
K232178 · KPR
DRGEM Corporation
Radiology · 57d
Cleared Sep 19, 2023
Millipede 088 Access Catheter
K231802 · QJP
Perfuze, Ltd.
Neurology · 91d
Cleared Sep 19, 2023
Aquilion Serve (TSX-307A/1) V1.3
K231281 · JAK
Canon Medical Systems Corporation
Radiology · 139d
Cleared Sep 19, 2023
Accuject Refra Injector AR2900
K231106 · MSS
Medicel AG
Ophthalmic · 153d
Cleared Sep 19, 2023
angiOCCLUDE Ligating Clips
K230966 · FZP
A2 Medical Systems, LLC
General & Plastic Surgery · 167d
Cleared Sep 19, 2023
Q Distal Access Catheter
K222948 · QJP
Mivi Neuroscience, Inc.
Neurology · 357d
Cleared Sep 19, 2023
AI100 with Shonit
K221309 · JOY
Sigtuple Technologies Pvt. , Ltd.
Hematology · 502d
Cleared Sep 18, 2023
Apollo ESG NXT System, Apollo REVISE NXT System
K232544 · QTD
Apollo Endosurgery, Inc.
Gastroenterology & Urology · 27d
Cleared Sep 18, 2023
Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
K232530 · OVD
Nexus Spine, LLC
Orthopedic · 28d