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
9097–9120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 2023
EZSensor XHD
K232255 · MUH
Qpix Solutions, Inc.
Radiology · 61d
Cleared Sep 27, 2023
VySpan™ PCT System
K232167 · NKG
Vy Spine, LLC
Orthopedic · 68d
Cleared Sep 27, 2023
FreedomFlow Orbital Circumferential Atherectomy System
K231538 · MCW
Cardio Flow Inc.,
Cardiovascular · 120d
Cleared Sep 27, 2023
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003,...
K231363 · NGT
Hantech Medical Device Co., Ltd.
General Hospital · 139d
Cleared Sep 27, 2023
Talon Transseptal Sheath
K231108 · DYB
Inari Medical, Inc.
Cardiovascular · 161d
Cleared Sep 27, 2023
VariLift®-C Interbody Fusion System
K231076 · ODP
Wenzel Spine, Inc.
Orthopedic · 166d
Cleared Sep 27, 2023
CEDIA Heroin Metabolite (6-AM) Assay
K231007 · DJG
Microgenics Corporation
Chemistry · 173d
Cleared Sep 27, 2023
Disposable Injection Needle AF series
K230925 · FBK
Alton (Shanghai) Medical Instruments...
Gastroenterology & Urology · 177d
Cleared Sep 27, 2023
EVOLUTION® Hinge Knee System
K230563 · KRO
Microport Orthopedics, Inc.
Orthopedic · 210d
Cleared Sep 27, 2023
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
K222638 · NJR
Cepheid
Microbiology · 391d
Cleared Sep 27, 2023
Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer
K214117 · LCP
Abbott Diagnostics Technologies AS
Chemistry · 636d
Cleared Sep 26, 2023
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic...
K232617 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Sep 26, 2023
ES Series V2
K232336 · IYN
E-Scopics
Radiology · 53d
Cleared Sep 26, 2023
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
K232233 · NXC
Align Technology, Inc.
Dental · 61d
Cleared Sep 26, 2023
DEKA PHYSIQ 360
K231971 · PKT
El.En S.P.A.
General & Plastic Surgery · 85d
Cleared Sep 26, 2023
AVVIGO'+ Multi-Modality Guidance System
K230884 · DQK
Boston Scientific Corporation
Cardiovascular · 180d
Cleared Sep 26, 2023
Arthrex Univers Apex OptiFit Humeral Stem
K230513 · KWS
Arthrex, Inc.
Orthopedic · 214d
Cleared Sep 26, 2023
MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
K230398 · JEY
Medcad
Dental · 222d
Cleared Sep 26, 2023
OFIX MIS App
K230252 · LLZ
Orthofix US, LLC
Radiology · 239d
Cleared Sep 26, 2023
Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC,...
K223496 · NHA
Prismatik Dentalcraft, Inc.
Dental · 309d
Cleared Sep 26, 2023
EasyStat 300
K220396 · CEM
Medica Corporation
Chemistry · 592d
Cleared Sep 26, 2023
Access Thyroglobulin Antibody II
K213517 · JZO
Beckman Coulter, Inc.
Immunology · 692d
Cleared Sep 25, 2023
IdentiTi ALIF Interbody Systems
K232097 · OVD
Alphatec Spine, Inc.
Orthopedic · 74d
Cleared Sep 25, 2023
PEACH 2, PEACH 2 Duo, PEACH 2 go
K231977 · OHT
Foreo, Inc.
General & Plastic Surgery · 84d