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
28177–28200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 28, 2017
PROCOTYL® PRIME E-CLASS™ XLPE Liner
K171181 · LZO
Microport Orthopedics, Inc.
Orthopedic · 126d
Cleared Aug 28, 2017
Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue...
K171561 · GDW
Dextera Surgical, Inc.
General & Plastic Surgery · 90d
Cleared Aug 28, 2017
IRIX-A Lumbar Integrated Fusion System
K171567 · OVD
X-Spine Systems, Inc.
Orthopedic · 90d
Cleared Aug 28, 2017
2 Hole Lateral Plating System
K172131 · KWQ
Life Spine, Inc.
Orthopedic · 45d
Cleared Aug 25, 2017
BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
K160378 · IMI
Brh Medical , Ltd.
Physical Medicine · 562d
Cleared Aug 25, 2017
ShenDa Sinuscope
K161298 · EOB
Shenyang Shenda Endoscope Co., Ltd.
Ear, Nose, Throat · 473d
Cleared Aug 25, 2017
Locking Cage, Full XPE Cup
K163441 · LZO
United Orthopedic Corporation
Orthopedic · 260d
Cleared Aug 25, 2017
Revolve Envi 600 Advanced Adipose System
K163647 · MUU
Lifecell Corporation
General & Plastic Surgery · 245d
Cleared Aug 25, 2017
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and...
K170136 · LZA
Shandong Feiyang Professional Gloves...
General Hospital · 220d
Cleared Aug 25, 2017
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with...
K171104 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 134d