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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68209–68232 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 2004
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ
K040367 · BYI
Electromed, Inc.
Anesthesiology · 54d
Cleared Apr 07, 2004
MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900
K040385 · FPA
Quest Medical, Inc.
General Hospital · 50d
Cleared Apr 07, 2004
TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
K040556 · EHD
Eastman Kodak Company
Radiology · 36d
Cleared Apr 07, 2004
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
K040569 · DTB
Oscor, Inc.
Cardiovascular · 34d
Cleared Apr 07, 2004
BLUEWAND LED DENTAL CURING WAND SYSTEM
K040614 · EBZ
J.L. Blosser, Inc.
Dental · 29d
Cleared Apr 07, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040619 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 29d
Cleared Apr 07, 2004
BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES
K040643 · DZE
Branemark Integration AB
Dental · 27d
Cleared Apr 07, 2004
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006,...
K040667 · FGE
Abbott Laboratories
Gastroenterology & Urology · 23d
Cleared Apr 07, 2004
MASTERSCREEN CPX AND OXYCON CPX
K040698 · BZC
Viasys Healthcare GmbH
Anesthesiology · 21d
Cleared Apr 07, 2004
DOSI-FUSER
K040752 · MEB
Leventon, S.A.
General Hospital · 14d
Cleared Apr 07, 2004
STRUCTUR 2 SC
K040769 · EBG
Voco GmbH
Dental · 13d
Cleared Apr 07, 2004
PROTAB ECG TABB ELECTRODE
K040784 · DRX
Bio Protech, Inc.
Cardiovascular · 9d
Cleared Apr 06, 2004
HEMOCLEAN
K023064 · NII
Krd Co., Ltd.
General Hospital · 568d
Cleared Apr 06, 2004
COOK URETERAL BALLOON DILATION CATHETER SET
K040127 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 76d
Cleared Apr 06, 2004
CADIMPLANT
K040224 · JAK
Praxim, Inc.
Radiology · 64d
Cleared Apr 06, 2004
HRV TOOLS
K040313 · DPS
Del Mar Reynolds Medical, Ltd.
Cardiovascular · 57d
Cleared Apr 05, 2004
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
K032139 · GGP
Corgenix, Inc.
Hematology · 269d
Cleared Apr 05, 2004
CUSTODIOL
K032794 · MSB
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 210d
Cleared Apr 05, 2004
DELIGHT DENTAL ER: YAG LASER SYSTEM
K032797 · GEX
Hoya Photonics, Inc.
General & Plastic Surgery · 210d
Cleared Apr 05, 2004
EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187
K032845 · HGY
The First Years, Inc.
Obstetrics & Gynecology · 207d
Cleared Apr 05, 2004
LOVELY SYSTEM
K033946 · FTC
Msq (M2) , Ltd.
General & Plastic Surgery · 108d
Cleared Apr 05, 2004
DYNATRAC, COD. 50-1A
K034051 · IYE
3D Line USA, Inc.
Radiology · 97d
Cleared Apr 05, 2004
SAFETYNET GUIDEWIRE INTRODUCER
K040029 · DYB
Injectimed, Inc.
Cardiovascular · 88d
Cleared Apr 05, 2004
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
K040111 · MOB
Zeus Scientific, Inc.
Immunology · 76d