FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
71113–71136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2003
COBAS INTEGRA CHOLESTEROL GEN. 2
K031824 · CHH
Roche Diagnostics Corp.
Chemistry · 26d
Cleared Jul 09, 2003
PROPHYPEARLS
K031868 · EFB
Kavo America
Dental · 22d
Cleared Jul 09, 2003
VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR
K031913 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 19d
Cleared Jul 09, 2003
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD...
K032040 · KFM
Dideco S.P.A.
Cardiovascular · 8d
Cleared Jul 08, 2003
NGT
K022558 · KNT
Medical Innovative Products
Gastroenterology & Urology · 340d
Cleared Jul 08, 2003
SUILE WOUND DRESSING
K022967 · FRO
Hedonist Biochemical Technologies...
General & Plastic Surgery · 305d
Cleared Jul 08, 2003
THE SUAD DEVICE
K023836 · LRK
Strong Dental, Inc.
Dental · 232d
Cleared Jul 08, 2003
INTRAOS 70
K031118 · EHD
Blue X Imaging Srl
Radiology · 91d
Cleared Jul 08, 2003
SEZ SAFETY SYRINGE
K031163 · MEG
Sez Corporation
General Hospital · 85d
Cleared Jul 08, 2003
CYNOSURE PHOTOLIGHT PL
K031258 · GEX
Cynosure, Inc.
General & Plastic Surgery · 78d
Cleared Jul 08, 2003
TERUMO SURGUARD 2 SAFETY NEEDLE
K031453 · FMI
Terumo Medical Corp.
General Hospital · 62d
Cleared Jul 08, 2003
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
K031555 · LXC
Synthes (Usa)
Orthopedic · 50d
Cleared Jul 08, 2003
CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM)
K031690 · GEX
Cynosure, Inc.
General & Plastic Surgery · 36d
Cleared Jul 08, 2003
5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
K031929 · LLZ
Wide Corporation
Radiology · 15d
Cleared Jul 07, 2003
RESPIRATORY HUMIDIFIER, MODEL MR850
K020332 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 522d
Cleared Jul 07, 2003
FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM
K024204 · GEX
Fotona D.D.
General & Plastic Surgery · 199d
Cleared Jul 07, 2003
PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM
K030076 · JKA
Biomed Personal Metabolic and...
Chemistry · 180d
Cleared Jul 07, 2003
VENTLAB BACTERIAL FILTER, MODEL BF100
K030271 · CAH
Ventlab Corp.
General Hospital · 161d
Cleared Jul 07, 2003
NXSTAGE SYSTEM ONE
K030470 · FII
Nxstage Medical, Inc.
Gastroenterology & Urology · 145d
Cleared Jul 07, 2003
ITI DENTAL IMPLANT SYSTEM
K031055 · DZE
Straumann USA
Dental · 95d
Cleared Jul 07, 2003
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
K031208 · MSV
Corgenix, Inc.
Immunology · 81d
Cleared Jul 07, 2003
MODEL 780
K031383 · BTT
Hudson Respiratory Care, Inc.
Anesthesiology · 67d
Cleared Jul 07, 2003
MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K031777 · FGE
Cordis Corp.
Gastroenterology & Urology · 27d
Cleared Jul 07, 2003
DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136,...
K031905 · FLL
Actherm, Inc.
General Hospital · 17d