FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
27553–27576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2017
Idys™ ALIF System
K172083 · OVD
Clariance, Sas
Orthopedic · 121d
Cleared Nov 08, 2017
SyndesMetrics Syndesmosis Repair System
K172620 · HTN
Mortise Medical, LLC
Orthopedic · 69d
Cleared Nov 08, 2017
RadiForce RX560, RX560-AR
K172738 · PGY
Eizo Corporation
Radiology · 57d
Cleared Nov 08, 2017
ER-REBOA Catheter
K172790 · MJN
Prytime Medical Devices, Inc.
Cardiovascular · 54d
Cleared Nov 08, 2017
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit,...
K173192 · GWM
Codman & Shurtleff, Inc.
Neurology · 37d
Cleared Nov 08, 2017
Surgical Planning Software version 1.1
K173247 · LLZ
Ortho Kinematics, Inc.
Radiology · 33d
Cleared Nov 07, 2017
Rooti Rx ECG Event Recorder, Rooti Link APP Software
K163694 · DRG
Rooti Labs , Ltd.
Cardiovascular · 314d
Cleared Nov 07, 2017
StatStrip Xpress Blood Glucose Monitoring System
K170464 · NBW
Nova Biomedical Corporation
Chemistry · 265d
Cleared Nov 07, 2017
IV Administration Sets
K170595 · FPA
B.Braun Medical, Inc.
General Hospital · 252d
Cleared Nov 07, 2017
Hintermann Series H2 Total Ankle System
K171004 · HSN
Dt Medtech, LLC
Orthopedic · 217d
Cleared Nov 07, 2017
Arthrex Knee Systems
K171365 · MBH
Arthrex, Inc.
Orthopedic · 182d
Cleared Nov 07, 2017
Compressyn™ Staple
K171473 · JDR
Dallen Medical, Inc.
Orthopedic · 172d
Cleared Nov 07, 2017
Insulia Diabetes Management Companion
K172177 · NDC
Voluntis Sa.
General Hospital · 111d
Cleared Nov 07, 2017
Lateral Spinal Truss System (LSTS) Interbody Fusion Device
K172392 · MAX
4Web, Inc.
Orthopedic · 91d
Cleared Nov 07, 2017
SPIRA-C Open Matrix Cervical Interbody
K172446 · ODP
Camber Spine Technologies
Orthopedic · 85d
Cleared Nov 07, 2017
NCompass Nitinol Stone Extractors
K173009 · LQR
Cook Incorporated
Gastroenterology & Urology · 41d
Cleared Nov 07, 2017
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
K173086 · LPL
Visioneering Technologies, Inc.
Ophthalmic · 39d
Cleared Nov 07, 2017
UltraVision 2 Diagnostic Ultrasound System
K173265 · IYN
Winprobe Corporation
Radiology · 27d
Cleared Nov 06, 2017
External Hex Implants
K163634 · DZE
Southern Implants (Pty), Ltd.
Dental · 319d
Cleared Nov 06, 2017
Omni Foot Plating System
K172260 · HRS
Extremity Medical, LLC
Orthopedic · 102d
Cleared Nov 06, 2017
EPIC Extremity Fracture Plate System
K172441 · HRS
Epic Extremity, LLC
Orthopedic · 87d
Cleared Nov 06, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and...
K172442 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 87d
Cleared Nov 06, 2017
XW-100 Automated Hematology Analyzer for CLIA Waived Use
K172604 · GKZ
Sysmex America, Inc.
Hematology · 68d
Cleared Nov 06, 2017
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel...
K172712 · FMK
Gri Medical & Electronic Technology...
General & Plastic Surgery · 59d