FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
28153–28176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2017
Orthopantomograph OP300
K163423 · OAS
Palodex Group OY
Radiology · 268d
Cleared Aug 31, 2017
Internal Octa Implant System
K170031 · DZE
Ebi, Inc.
Dental · 239d
Cleared Aug 31, 2017
SureFlo EVD Catheter
K170599 · JXG
Arkis Biosciences, Inc.
Neurology · 183d
Cleared Aug 31, 2017
Latitude EV Total Elbow Arthroplasty
K171010 · JDB
Tornier, Inc.
Orthopedic · 149d
Cleared Aug 31, 2017
Arctic Sperm Cryopreservation Medium
K171224 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 127d
Cleared Aug 31, 2017
Additional VIPER PRIME™ screws with fenestrations
K171570 · NKB
Medos International SARL
Orthopedic · 93d
Cleared Aug 31, 2017
Atellica IM Ferritin Assay
K171642 · DBF
Siemens Healthcare Diagnostics, Inc.
Immunology · 90d
Cleared Aug 31, 2017
CAPRI Corpectomy Cage System
K171704 · MQP
K2m
Orthopedic · 84d
Cleared Aug 31, 2017
MAGEC® System
K171791 · PGN
Nuvasive Specialized Orthopedics,...
Orthopedic · 76d
Cleared Aug 31, 2017
Pirouette High Pressure (HP)
K172033 · LIT
Arravasc, Ltd.
Cardiovascular · 57d
Cleared Aug 31, 2017
DUS-7000 Digital Color Doppler Ultrasound System
K172055 · IYN
Advanced Instrumentations, Inc.
Radiology · 56d
Cleared Aug 31, 2017
Medical Video Endoscope System
K172098 · FGB
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 51d
Cleared Aug 31, 2017
SHOFU MZ Primer Plus
K172106 · KLE
Shofu Dental Corporation
Dental · 50d
Cleared Aug 30, 2017
SmartTouch
K163485 · CAF
Adherium (Nz), Ltd.
Anesthesiology · 261d
Cleared CT 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 CT 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