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
30193–30216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 2017
Trapper Exchange Device
K162253 · DQY
Creganna Medical Aslo Business AS...
Cardiovascular · 149d
Cleared Jan 06, 2017
Disc-FX System
K162490 · GEI
Elliquence, LLC
General & Plastic Surgery · 121d
Cleared Jan 06, 2017
PrismaSATE
K162887 · KPO
Baxter Healthcare Corporation
Gastroenterology & Urology · 81d
Cleared Jan 06, 2017
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
K162931 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 79d
Cleared Jan 06, 2017
8ch Knee-Foot SPEEDER
K162946 · MOS
Quality Electrodynamics, LLC
Radiology · 77d
Cleared Jan 06, 2017
LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
K162969 · LFZ
DiaSorin, Inc.
Microbiology · 74d
Cleared Jan 06, 2017
Quantib Brain 1.2
K163013 · LLZ
Quantib B.V.
Radiology · 70d
Cleared Jan 06, 2017
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3
K163116 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 60d
Cleared Jan 06, 2017
NAMIC ClearaCIL Contrast Injection Lines
K163141 · DQO
AngioDynamics, Inc.
Cardiovascular · 58d
Cleared Jan 06, 2017
SpeedStitch Suture Passer
K163142 · GAT
ArthroCare Corporation
General & Plastic Surgery · 58d
Cleared Jan 06, 2017
Spectre guidewire
K163444 · DQX
Vascular Solutions, Inc.
Cardiovascular · 29d
Cleared Jan 06, 2017
DuraGen Secure Dural Regeneration Matrix
K163456 · GXQ
Integra LifeSciences Corporation
Neurology · 28d
Cleared Jan 06, 2017
NeuraGen 3D Nerve Guide Matrix
K163457 · JXI
Integra LifeSciences Corporation
Neurology · 28d
Cleared Jan 06, 2017
StatStrip Xpress 2 Glucose Hospital Meter System
K163490 · PZI
Nova Biomedical Corporation
Chemistry · 25d
Cleared Jan 06, 2017
Oracle EUS Balloon
K163492 · FDF
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 24d
Cleared Jan 05, 2017
AGNES
K160469 · GEI
Gowoonsesang Cosmetics Co., Ltd.
General & Plastic Surgery · 321d
Cleared Jan 05, 2017
Chaorum Implant System
K160536 · DZE
Medimecca Co., Ltd.
Dental · 314d
Cleared Jan 05, 2017
C2 Cryoballoon Ablation System
K161202 · GEH
C2 Therapeutics, Inc.
General & Plastic Surgery · 252d
Cleared Jan 05, 2017
EasyOne Air Spirometer
K161536 · BZG
Ndd Medizintechnik AG
Anesthesiology · 216d
Cleared Jan 05, 2017
Poseidon OCT Spinal Fixation System
K161637 · NKG
Medyssey USA, Inc.
Orthopedic · 205d
Cleared Jan 05, 2017
LOSPA IS ACP System
K161641 · KWQ
Corentec Co., Ltd.
Orthopedic · 205d
Cleared Jan 05, 2017
CrossBay IVF Embryo Transfer Catheter Set
K162064 · MQF
Crossbay Medical, Inc.
Obstetrics & Gynecology · 163d
Cleared Jan 05, 2017
Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)
K162146 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 157d
Cleared Jan 05, 2017
Turbo-Power (2.0mm) Laser Atherectomy Catheters
K162561 · MCW
Spectranetics, Inc.
Cardiovascular · 113d