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
37969–37992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2014
ACUITY PRO LEAD DELIVERY SYSTEM
K132914 · DQY
Boston Scientific
Cardiovascular · 198d
Cleared Apr 03, 2014
VIZION ULTRA
K133139 · MQB
Viztek, LLC
Radiology · 168d
Cleared Apr 03, 2014
ALEUTIAN IBF SYSTEM
K133614 · MAX
K2m, Inc.
Orthopedic · 129d
Cleared Apr 03, 2014
DEPUY GLOBAL UNITE SHOULDER SYSTEM
K133834 · KWS
Depuy(Ireland)
Orthopedic · 107d
Cleared Apr 03, 2014
VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE
K133914 · LHN
Medcom GmbH
Radiology · 101d
Cleared Apr 03, 2014
COROENT SMALL INTERBODY SYSTEM
K140003 · ODP
Nuvasive, Inc.
Orthopedic · 91d
Cleared Apr 03, 2014
DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
K140043 · LZO
Microport Orthopedics, Inc.
Orthopedic · 85d
Cleared Apr 03, 2014
CRYOTOP(R) SC
K140072 · MQK
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 80d
Cleared Apr 03, 2014
SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
K140131 · FPA
Emed Technologies Corporation
General Hospital · 76d
Cleared Apr 03, 2014
VARIAX 2 SYSTEM
K140376 · HRS
Stryker Trauma AG
Orthopedic · 48d
Cleared Apr 03, 2014
MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET,...
K140402 · LHI
Medsource International, LLC
General Hospital · 44d
Cleared Apr 03, 2014
MACH LED 2SC
K140460 · FSY
Dr. Mach GmbH & Co. KG
General & Plastic Surgery · 38d
Cleared Apr 03, 2014
MACH LED 2MC
K140461 · FSY
Dr. Mach GmbH & Co. KG
General & Plastic Surgery · 38d
Cleared Apr 02, 2014
AHP 300, EMERGENCY PORTABLE VENTILATOR
K132021 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 274d
Cleared Apr 02, 2014
INNESIS PEEK CERVICAL CAGE
K132483 · ODP
Bk Meditech, Co., Ltd.
Orthopedic · 237d
Cleared Apr 02, 2014
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K133933 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 100d
Cleared Apr 02, 2014
SIGNATURE PLANNER, SIGNATURE GUIDES
K140257 · MBH
Materialise NV
Orthopedic · 58d
Cleared Apr 01, 2014
OMNYX IDP FOR HER2 MANUAL APPLICATION
K131140 · OEO
Omnyx, LLC
Pathology · 344d
Cleared Apr 01, 2014
N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE...
K133606 · MBI
ArthroCare Corporation
Orthopedic · 127d
Cleared Apr 01, 2014
MODIFIED DISTAL RADIUS PLATING SYSTEM
K133939 · HRS
Biomet
Orthopedic · 99d
Cleared Apr 01, 2014
VUPAD
K140199 · IYO
Sonomed, Inc.
Radiology · 64d
Cleared Apr 01, 2014
VARIAX CLAVICLE HOOK PLATE
K140259 · HRS
Stryker Trauma AG
Orthopedic · 57d
Cleared Apr 01, 2014
TABLET VIEWER SOFTWARE FOR IMAGE SUITE
K140271 · LLZ
Carestream Health, Inc.
Radiology · 57d
Cleared Apr 01, 2014
IMBIBE NEEDLE
K140414 · LXH
Orthovita, Inc.
Orthopedic · 42d