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
21457–21480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 2019
NeuroOne Cortical Electrode
K192764 · GYC
Neuroone, Inc.
Neurology · 57d
Cleared Nov 26, 2019
Advocate PTA Catheter
K192907 · LIT
Merit Medical Systems, Inc.
Cardiovascular · 42d
Cleared Nov 26, 2019
Pinnacle Duofix HA Acetabular Cup Prosthesis
K192919 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 42d
Cleared Nov 26, 2019
DePuy Corail AMT Hip Prosthesis
K192946 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 39d
Cleared Nov 25, 2019
Pivot System Sterilization case
K181845 · KCT
Rp Medical, Inc.
General Hospital · 502d
Cleared Nov 25, 2019
Infant Incubator
K190494 · FMZ
Ningbo David Medical Device Co., Ltd.
General Hospital · 270d
Cleared Nov 25, 2019
SOZO
K190529 · QJB
ImpediMed Limited
Gastroenterology & Urology · 266d
Cleared Nov 25, 2019
Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK...
K190590 · MQE
Allwin Medical Devices, Inc.
Obstetrics & Gynecology · 263d
Cleared Nov 25, 2019
VS3-IR
K191851 · OWN
Medtronic
General & Plastic Surgery · 138d
Cleared Nov 25, 2019
Cortina™ [MAX] Lumbar Cage System
K192248 · MAX
Neurostructures, Inc.
Orthopedic · 98d
Cleared Nov 25, 2019
Blue Latex Examination Powder Free Gloves
K192329 · LYY
Jr Engineering & Medical Technologies...
General Hospital · 90d
Cleared Nov 25, 2019
ADVIA Centaur Cortisol (COR)
K192788 · JFT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Nov 23, 2019
DEXIS CariVu 3-in-1 by KaVo
K182712 · NTK
Kaltenbach & Voigt GmbH
Dental · 422d
Cleared Nov 23, 2019
Cadwell Bolt Software
K190760 · OLT
Cadwell Industries, Inc.
Neurology · 243d
Cleared Nov 22, 2019
Revitalair 430F
K171899 · CBF
Oxavita Srl
Anesthesiology · 879d
Cleared Nov 22, 2019
Applied Medical Laparoscopic Linear Cutter
K190331 · GDW
Applied Medical Resources Corporation
General & Plastic Surgery · 281d
Cleared Nov 22, 2019
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
K190512 · FDI
Intelligent Endoscopy
Gastroenterology & Urology · 266d
Cleared Nov 22, 2019
Color Liquid, Vita Liquid
K190518 · EIH
Zirkonzahn Srl
Dental · 263d
Cleared Nov 22, 2019
PREVENA PLUS Incision Management System (No Ag)
K190697 · OMP
Kci USA, Inc.
General & Plastic Surgery · 249d
Cleared Nov 22, 2019
Navina Smart System, Navina Classic System
K190977 · KNT
Dentsply Sirona
Gastroenterology & Urology · 221d
Cleared Nov 22, 2019
KLS Martin Individual Patient Solutions
K191028 · JEY
KLS-Martin L.P.
Dental · 218d
Cleared Nov 22, 2019
Healy
K191075 · NUH
Timewaver Production GmbH
Neurology · 213d
Cleared Nov 22, 2019
Parkell Desensitizer Gel
K191103 · EJK
Parkell, Inc.
Dental · 211d
Cleared Nov 22, 2019
3M™ Attest™ Steam Chemical Integrators
K191236 · JOJ
3M Company
General Hospital · 198d