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
18265–18288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 2020
JianYu Surgical Mask
K201754 · FXX
Jiangsu Jianyu Health Medical Co., Ltd.
General Hospital · 184d
Cleared Dec 30, 2020
Foley Balloon Catheter for Urology
K201776 · EZL
Apollon Co., Ltd.
Gastroenterology & Urology · 184d
Cleared Dec 30, 2020
CryoTreQ
K202038 · HPS
Vitreq BV
Ophthalmic · 160d
Cleared Dec 30, 2020
CrossRoads Tray System
K202268 · KCT
Crossroads Extremity Systems, LLC
General Hospital · 141d
Cleared Dec 30, 2020
Upper Arm Electronic Blood Pressure Monitor
K202372 · DXN
Conmo Electronic Company Limited
Cardiovascular · 133d
Cleared Dec 30, 2020
Remunity Pump for Remodulin (treprostinil) Injection
K202690 · QJY
Deka Research and Development
General Hospital · 106d
Cleared Dec 30, 2020
PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical...
K203166 · ODG
Pentax of America, Inc.
Gastroenterology & Urology · 68d
Cleared Dec 30, 2020
Arthrex Low Profile Screws
K203239 · HWC
Arthrex, Inc.
Orthopedic · 57d
Cleared Dec 29, 2020
XR-MX/1000
K200965 · JAA
KARL STORZ Endoscopy-America, Inc.
Radiology · 263d
Cleared Dec 29, 2020
Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 &...
K202455 · IYN
Supersonic Imagine
Radiology · 124d
Cleared Dec 29, 2020
M5 Recorder
K202456 · DSH
Global Instrumentation, LLC
Cardiovascular · 124d
Cleared Dec 29, 2020
E-Cath STIM acc. Tsui
K202699 · CAZ
PAJUNK GmbH Medizintechnologie
Anesthesiology · 104d
Cleared Dec 29, 2020
First Relief v1
K202940 · QHH
Dyansys, Inc.
Neurology · 90d
Cleared Dec 29, 2020
Venue Fit
K203137 · IYN
GE Medical Systems Ultrasound and...
Radiology · 70d
Cleared Dec 29, 2020
Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever
K203219 · POL
Stryker Neurovascular
Neurology · 57d
Cleared Dec 29, 2020
BriefCase
K203508 · QAS
Aidoc Medical , Ltd.
Radiology · 29d
Cleared Dec 29, 2020
Baby Gorilla/Gorilla Plating System
K203511 · HRS
Paragon 28, Inc.
Orthopedic · 29d
Cleared Dec 28, 2020
Novaerus NV1050
K200321 · FRF
Novaerus Us, Inc.
General Hospital · 322d
Cleared Dec 28, 2020
Tailored-C Cervical Interbody Fusion System
K200458 · ODP
Bespoke Technologies
Orthopedic · 307d
Cleared Dec 28, 2020
ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R
K200968 · CBI
Insung Medical Co., Ltd.
Anesthesiology · 262d
Cleared Dec 28, 2020
Self-Contained Biological Indicator
K200970 · FRC
True Indicating, LLC
General Hospital · 259d
Cleared Dec 28, 2020
Uni-FuZe-P Bone Putty
K201781 · MQV
Zavation Medical Products, LLC
Orthopedic · 181d
Cleared Dec 28, 2020
Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)
K201800 · EHD
Nanoray Co., Ltd.
Radiology · 181d
Cleared Dec 28, 2020
Attune Revision Sleeve LPS Femoral Adaptors
K202248 · JWH
Depuy Ireland UC
Orthopedic · 140d