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
16057–16080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2021
Acuitas AMR Gene Panel
K191288 · PMY
Opgen, Inc.
Microbiology · 871d
Cleared Sep 30, 2021
Intravascular Administration Sets
K203609 · FPA
Baxter Healthcare Corporation
General Hospital · 294d
Cleared Sep 30, 2021
Implanova
K210523 · DZE
Dental Evolutions, Inc.
Dental · 219d
Cleared Sep 30, 2021
Small Bone Nailing System
K211439 · HTY
Skeletal Dynamics, Inc.
Orthopedic · 143d
Cleared Sep 30, 2021
Playboy 3 Contour Condom
K211450 · HIS
Thai Nippon Rubber Industry Public...
Obstetrics & Gynecology · 143d
Cleared Sep 30, 2021
NAEOTOM Alpha, Scan&GO
K211591 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 129d
Cleared Sep 30, 2021
Enteral Pump Syringe
K211593 · PNR
Jiangsu Caina Medical Co.,Ltd
Gastroenterology & Urology · 129d
Cleared Sep 30, 2021
ORIO-Ti Intervertebral Body Fusion Cage System
K211935 · ODP
Spinecraft, LLC
Orthopedic · 100d
Cleared Sep 30, 2021
Philips IntelliVue GuardianSoftware (Rev. E.0X)
K212208 · DXJ
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 77d
Cleared Sep 30, 2021
Philips MR Patient Care Portal
K212227 · MWI
Invivo Corporation
Cardiovascular · 76d
Cleared Sep 30, 2021
AngioVac F18 85
K212386 · DWF
AngioDynamics, Inc.
Cardiovascular · 59d
Cleared Sep 30, 2021
EMERGE™ Anterior Cervical Plate System
K212405 · KWQ
Evolution Spine
Orthopedic · 59d
Cleared Sep 30, 2021
Jada System
K212757 · OQY
Alydia Health
Obstetrics & Gynecology · 30d
Cleared Sep 30, 2021
Accuray Precision Treatment Planning System
K212794 · IYE
Accuray Incorporated
Radiology · 28d
Cleared Sep 30, 2021
SteriCap Mini Needle and Standard Needles
K212805 · FMI
Ocuject, LLC
General Hospital · 28d
Cleared Sep 29, 2021
LAP-iX
K200639 · GEI
Sejong Medical Co., Ltd.
General & Plastic Surgery · 568d
Cleared Sep 29, 2021
ENDOtube
K203350 · OCX
Nissha Medical Technologies Sas
Gastroenterology & Urology · 320d
Cleared Sep 29, 2021
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit...
K203668 · BSP
Myco Medical Supplies, Inc.
Anesthesiology · 287d
Cleared Sep 29, 2021
UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM...
K210513 · FXX
Universal Incorporation
General Hospital · 218d
Cleared Sep 29, 2021
Axis Spine Technologies ALIF
K210590 · OVD
Axis Spine Technologies, Ltd.
Orthopedic · 212d
Cleared Sep 29, 2021
ImmersiveTouch
K210726 · LLZ
Immersivetouch, Inc.
Radiology · 202d
Cleared Sep 29, 2021
Inman Digital Clear Aligners
K210763 · NXC
Inman Orthodontic Laboratories, Inc.
Dental · 198d
Cleared Sep 29, 2021
DualX
K211740 · MAX
Amplify Surgical, Inc.
Orthopedic · 114d
Cleared Sep 29, 2021
Disposable Nitrile Gloves
K211781 · LZA
Jiangsu Jinke Protective Equipment...
General Hospital · 112d