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
26065–26088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2018
Osteotomy Truss System (OTS)
K172294 · HRS
4Web, Inc.
Orthopedic · 206d
Cleared Feb 22, 2018
Medline Catheter Specimen Collector
K172541 · EZD
Medline Industries, Inc.
Gastroenterology & Urology · 183d
Cleared Feb 22, 2018
LightForce LTS Model 1000, 1500, 2500, and 4000
K173067 · GEX
Litecure, LLC
General & Plastic Surgery · 146d
Cleared Feb 22, 2018
Sentry IVC Filter
K173236 · DTK
Novate Medical , Ltd.
Cardiovascular · 140d
Cleared Feb 22, 2018
Talon DistalFix Humeral Nail
K173255 · HSB
Orthopedic Designs North America, Inc.
Orthopedic · 135d
Cleared Feb 22, 2018
SeaSpine Spinous Process System
K173334 · PEK
SeaSpine Orthopedics Corporation
Orthopedic · 122d
Cleared Feb 22, 2018
Nexxis OR
K173381 · DXJ
Barco N.V.
Cardiovascular · 115d
Cleared Feb 22, 2018
Neocis Guidance System (NGS) with Chairside Splint
K173402 · PLV
Neocis, Inc.
Dental · 114d
Cleared Feb 22, 2018
Amsco Evolution Medium Steam Sterilizer
K173485 · FLE
STERIS Corporation
General Hospital · 101d
Cleared Feb 22, 2018
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
K173490 · FLE
STERIS Corporation
General Hospital · 101d
Cleared Feb 22, 2018
Remedy Acetabular Cup
K173967 · KWL
Osteoremedies, LLC
Orthopedic · 55d
Cleared Feb 22, 2018
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
K180004 · LPL
Menicon Co, Ltd.
Ophthalmic · 51d
Cleared Feb 22, 2018
Natus Quantum
K180181 · GWQ
Natus Medical Incorporated Dba...
Neurology · 30d
Cleared Feb 21, 2018
Captura Disposable Bronchoscope Biopsy Forceps
K163377 · EOQ
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 447d
Cleared Feb 21, 2018
Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579
K170866 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 335d
Cleared Feb 21, 2018
PiCCO Catheter
K171620 · KRB
Pulsion Medical Systems SE
Cardiovascular · 264d
Cleared Feb 21, 2018
Catasyn Advanced Technology Wound Hydrogel
K172338 · FRO
Synedgen, Inc.
General & Plastic Surgery · 203d
Cleared Feb 21, 2018
Reprocessed ArthroCare ENT Coblator
K172647 · NUJ
Renovo, Inc.
General & Plastic Surgery · 173d
Cleared Feb 21, 2018
TSN Transseptal Needle
K172950 · DRC
Pressure Products Medical Device...
Cardiovascular · 148d
Cleared Feb 21, 2018
Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles
K173626 · FRC
STERIS Corporation
General Hospital · 89d
Cleared Feb 21, 2018
CELERITY 20 Steam Process Challenge Device for Gravity Cycles
K173629 · FRC
STERIS Corporation
General Hospital · 89d
Cleared Feb 21, 2018
DRI Benzodiazepine Assay
K173963 · JXM
Microgenics Corporation
Toxicology · 55d
Cleared Feb 21, 2018
DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
K180193 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 28d
Cleared Feb 20, 2018
Aesculap Video Assisted Thoracic Surgery (VATS) INstruments
K170683 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 350d