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
27577–27600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2017
Idylla Respiratory (IFV-RSV) Panel
K163628 · OCC
Janssen Pharmaceutica NV
Microbiology · 251d
Cleared Aug 30, 2017
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K170467 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 195d
Cleared Aug 30, 2017
MyndMove System, MyndMove Functional Electrical Stimulator
K170564 · GZI
Myndtec, Inc.
Neurology · 184d
Cleared Aug 30, 2017
K2M Navigation Instruments
K171321 · OLO
K2m
Orthopedic · 118d
Cleared Aug 30, 2017
Refobacin Bone Cement R
K171540 · LOD
Biomet, Inc.
Orthopedic · 96d
Cleared Aug 30, 2017
truFreeze System
K171626 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 89d
Cleared Aug 30, 2017
Astroglide O Oil Personal Lubricant & Massage Oil
K171985 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 58d
Cleared Aug 30, 2017
LigaPASS
K172021 · OWI
Medicrea International SA
Orthopedic · 56d
Cleared Aug 30, 2017
CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED
K172049 · GEH
Cry IQ AB
General & Plastic Surgery · 55d
Cleared Aug 30, 2017
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC...
K172274 · JWY
Thermo Fisher Scientific
Microbiology · 33d
Cleared Aug 29, 2017
ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable...
K162165 · MEA
Summit Medical Products, Inc.
General Hospital · 391d
Cleared Aug 29, 2017
SyMRI
K162943 · LNH
Syntheticmr AB
Radiology · 312d
Cleared Aug 29, 2017
Cortex Dental Implant System
K163385 · DZE
Cortex Dental Implants Industries , Ltd.
Dental · 270d
Cleared Aug 29, 2017
ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
K170958 · DXC
Tricol Biomedical, Inc.
Cardiovascular · 151d
Cleared Aug 29, 2017
Assut Filbloc Permanent Sutures
K171039 · GAW
Assut Europe S.P.A.
General & Plastic Surgery · 145d
Cleared Aug 29, 2017
Altus Spine Titanium Interbody Fusion System
K171329 · MAX
Altus Partners, LLC
Orthopedic · 116d
Cleared Aug 29, 2017
Easyscreen
K171506 · EWO
Maico Diagnostics GmbH
Ear, Nose, Throat · 98d
Cleared Aug 29, 2017
CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver
K171592 · MAI
Conmed Corporation
Orthopedic · 90d
Cleared Aug 29, 2017
Laport
K171741 · GCJ
Sejong Medical Co., Ltd.
General & Plastic Surgery · 78d
Cleared Aug 29, 2017
Feminine Personal Trainer (FPT)
K171896 · HIR
Ralston Group
Gastroenterology & Urology · 64d
Cleared Aug 28, 2017
Reverse Pull Adjustable Facemask
K162543 · DZB
Sawbros Industries Pvt., Ltd.
Dental · 350d
Cleared Aug 28, 2017
Salle Intraoperative Pyeloplasty Stent Set
K170010 · FAD
Cook Incorporated
Gastroenterology & Urology · 237d
Cleared Aug 28, 2017
Moxxly Flow Collection System
K170722 · HGX
Moxxly, Inc.
Obstetrics & Gynecology · 172d
Cleared Aug 28, 2017
Captus Vascular Retrieval System
K170987 · MMX
Avantec Vascular Corporation
Cardiovascular · 147d