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
35929–35952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL...
K142118 · NHA
Prismatik Dentalcraft, Inc.
Dental · 113d
Cleared Nov 25, 2014
Atricure Cryo Module System
K142203 · GXH
AtriCure, Inc.
Neurology · 106d
Cleared Nov 25, 2014
LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200...
K142270 · LYY
Hartalega Sdb. Bhd.
General Hospital · 102d
Cleared Nov 25, 2014
SNaP Wound Care System
K142272 · OKO
Spiracur, Inc.
General & Plastic Surgery · 102d
Cleared Nov 25, 2014
CoRoent Small Interlock System
K142299 · OVE
Nu Vasive, Incorporated
Orthopedic · 99d
Cleared Nov 25, 2014
Hospira Primary Sets
K142367 · FPA
Hospira, Inc.
General Hospital · 92d
Cleared Nov 25, 2014
Variolink Esthetic
K142389 · EBF
Ivoclar Vivadent, AG
Dental · 90d
Cleared Nov 25, 2014
PREDICATE III GUIDEWIRE
K142393 · DQX
Lake Region Medical
Cardiovascular · 90d
Cleared Nov 25, 2014
Masimo Root Monitoring System and Accesories
K142394 · MWI
Masimo Corporation
Cardiovascular · 90d
Cleared Nov 25, 2014
DR300 HOLTER MONITOR
K142424 · MWJ
North East Monitoring, Inc.
Cardiovascular · 88d
Cleared Nov 25, 2014
VASCU-GUARD Peripheral Vascular Patch
K142461 · DXZ
Synovis Life Technologies, Inc.
Cardiovascular · 84d
Cleared Nov 25, 2014
Univers Rivers Shoulder Prosthesis System
K142863 · PHX
Arthrex, Inc.
Orthopedic · 55d
Cleared Nov 25, 2014
Sherpa Pak Kidney Transport System
K143054 · KDN
Paragonix Technologies, Inc.
Gastroenterology & Urology · 33d
Cleared Nov 25, 2014
Sherpa Pak Cardiac Transport System
K143074 · MSB
Paragonix Technologies, Inc.
Gastroenterology & Urology · 29d
Cleared Nov 24, 2014
HUMICARE D900
K133766 · BTT
Gruendler GmbH
Anesthesiology · 348d
Cleared Nov 24, 2014
SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE
K140566 · JOJ
Crosstex International
General Hospital · 264d
Cleared Nov 24, 2014
WOUNDCLOT HEMOSTATIC GAUZE
K140573 · QSY
Core Scientific , Ltd.
General & Plastic Surgery · 263d
Cleared Nov 24, 2014
OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE
K140716 · MAX
Interventional Spine, Inc.
Orthopedic · 248d
Cleared Nov 24, 2014
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
K141682 · OGZ
Infraredx, Inc.
Cardiovascular · 154d
Cleared Nov 24, 2014
TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT
K141939 · BTR
Teleflexmedical, Inc.
Anesthesiology · 130d
Cleared Nov 24, 2014
CONCHASMART COLUMN
K141940 · BTT
Teleflex, Inc.
Anesthesiology · 130d
Cleared Nov 24, 2014
ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH...
K141952 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 129d
Cleared Nov 24, 2014
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
K142072 · KWS
Custom Orthopaedic Solutions, Inc.
Orthopedic · 124d
Cleared Nov 24, 2014
SIGNA PET/MR
K142098 · OUO
Ge Medical Systems, LLC
Radiology · 115d