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
26761–26784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 2018
V-PRO maX 2 Low Temperature Sterilization System
K172754 · MLR
STERIS Corporation
General Hospital · 150d
Cleared Feb 09, 2018
PRO-LITE Sterilization Trays
K172755 · KCT
STERIS Corporation
General Hospital · 150d
Cleared Feb 09, 2018
ChlorCid, ChlorCid V, ChlorCid Surf
K173163 · KJJ
Ultradent Products, Inc.
Dental · 133d
Cleared Feb 09, 2018
Ergonomic Handle
K173272 · GCJ
Symmetry Surgical, Inc.
General & Plastic Surgery · 120d
Cleared Feb 09, 2018
ORISE Tissue Retractor System
K173400 · FED
Boston Scientific
Gastroenterology & Urology · 101d
Cleared Feb 09, 2018
3M Attest Rapid Readout Biological Indicator
K173435 · FRC
3M Company
General Hospital · 98d
Cleared Feb 09, 2018
Meridian Vaginal Positioning System (VPS)
K173501 · PWK
Coloplast
Obstetrics & Gynecology · 88d
Cleared Feb 09, 2018
BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam...
K173523 · LON
Becton, Dickinson and Company
Microbiology · 87d
Cleared Feb 09, 2018
Leksell GammaPlan
K173791 · IWB
Elekta Instrument AB
Radiology · 57d
Cleared Feb 09, 2018
Amrad Medical AAU Digital Radiography System
K173823 · KPR
Summit Industries, LLC
Radiology · 53d
Cleared Feb 09, 2018
Jade PTA Balloon Dilatation Catheter
K173894 · LIT
Orbusneich Medical Trading, Inc.
Cardiovascular · 50d
Cleared Feb 09, 2018
Blue Sky Bio Aligner
K180107 · NXC
Blue Sky Bio, LLC
Dental · 24d
Cleared Feb 08, 2018
SENYINT Remote Consultation System
K162727 · LLZ
Dalian Senyint Digital Medical System...
Radiology · 497d
Cleared Feb 08, 2018
NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System
K173025 · MAX
Nu Vasive, Incorporated
Orthopedic · 133d
Cleared Feb 08, 2018
superDimension Navigation System V7.2
K173244 · JAK
Covidien, LLC
Radiology · 125d
Cleared Feb 08, 2018
Gazelle PTFE and Suture Delivery Device
K173335 · NBY
Dura Tap, LLC
General & Plastic Surgery · 108d
Cleared Feb 08, 2018
Comprehensive Segmental Revision System (SRS)
K173411 · PHX
Biomet Manufacturing Corp
Orthopedic · 99d
Cleared Feb 08, 2018
CONCORDE LIFT™
K173537 · MAX
Medos International SARL
Orthopedic · 85d
Cleared Feb 08, 2018
LUCAS 3 Chest Compression System
K173553 · DRM
Jolife AB
Cardiovascular · 84d
Cleared Feb 08, 2018
NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm),...
K173805 · MSD
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 55d
Cleared Feb 08, 2018
Ultrasound System SONIMAGE MX1
K180084 · IYO
Konica Minolta, Inc.
Radiology · 28d
Cleared Feb 08, 2018
UNiD Spine Analyzer
K180091 · LLZ
Medicrea International
Radiology · 27d
Cleared Feb 07, 2018
PENTAX MEDICAL ED-3490TK, Video Duodenoscope
K161222 · FDT
Pentax Medical
Gastroenterology & Urology · 649d
Cleared Feb 07, 2018
SteriZign Signatur Device Protection System
K171520 · KCT
Sterizign Precision Technologies, LLC
General Hospital · 259d