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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
8905–8928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 18, 2023
X-Twist Biocomposite Suture Anchor
K232513 · MAI
Parcus Medical
Orthopedic · 31d
Cleared Sep 18, 2023
BTL-785BNF Handpiece
K232172 · NFO
BTL Industries, Inc.
Neurology · 59d
Cleared Sep 18, 2023
Access Myoglobin
K231832 · DDR
Beckman Coulter, Inc.
Chemistry · 88d
Cleared Sep 18, 2023
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
K231663 · LRK
Innovative Health Technologies (Nz),...
Dental · 103d
Cleared Sep 18, 2023
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201,...
K231367 · DXN
Shenzhen Finicare Co., Ltd.
Cardiovascular · 130d
Cleared Sep 18, 2023
MA-40, MA-112
K223835 · FRF
Medify Air, LLC
General Hospital · 270d
Cleared Sep 18, 2023
B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA...
K222251 · QXS
B.R.A.H.M.S GmbH, Part of Thermo Fisher
Immunology · 418d
Cleared Sep 16, 2023
ImPACT Version 4
K231688 · POM
Impact Applications, Inc.
Neurology · 99d
Cleared Sep 16, 2023
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
K230483 · CAH
Passy-Muir, Inc.
General Hospital · 205d
Cleared Sep 15, 2023
Barrier EasyWarm Active Self-Warming Blanket
K232508 · DWJ
Molnlycke Health Care Us, LLC
Cardiovascular · 28d
Cleared Sep 15, 2023
Catalyst Bone Void Filler
K232315 · MQV
Ossdsign AB
Orthopedic · 44d