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
28033–28056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 2017
Glidewire GT
K170417 · DQX
Terumo Corporation
Cardiovascular · 217d
Cleared Sep 15, 2017
Phoenix Clinical ICON
K170527 · HKI
Phoenix Technology Group, Inc. Dba...
Ophthalmic · 205d
Cleared Sep 15, 2017
Medentika CAD/CAM TiBases
K170838 · NHA
Medentika GmbH
Dental · 178d
Cleared Sep 15, 2017
Leksell Vantage Stereotactic System
K171123 · HAW
Elekta Instrument AB
Neurology · 151d
Cleared Sep 15, 2017
M-CATH Microcatheter
K171176 · DQY
Acrostak (Schweiz) AG
Cardiovascular · 147d
Cleared CT Sep 15, 2017
Cefaly Acute
K171446 · PCC
Cefaly Technology
Neurology · 122d
Cleared Sep 15, 2017
FLXfit™
K171519 · MAX
Expanding Orthopedics, Inc.
Orthopedic · 114d
Cleared Sep 15, 2017
Fresenius Liberty Select Cycler
K171652 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 102d
Cleared Sep 15, 2017
Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
K171686 · MQP
Choicespine
Orthopedic · 100d
Cleared Sep 15, 2017
WowGoHealth Blood Glucose Monitoring System
K171785 · NBW
Biotest Medical Corporation
Chemistry · 92d
Cleared Sep 15, 2017
Stryker Consolidated Operating Room Equipment (CORE) 2 Console
K171840 · ERL
Stryker Corporation
Ear, Nose, Throat · 87d
Cleared Sep 15, 2017
Ti-Diagon Oblique TLIF
K172064 · MAX
Camber Spine Technologies
Orthopedic · 70d
Cleared Sep 15, 2017
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
K172150 · JWY
bioMerieux, Inc.
Microbiology · 60d
Cleared Sep 15, 2017
BladderScan Prime PLUS System
K172356 · IYO
Verathon Incorporated
Radiology · 43d
Cleared Sep 15, 2017
PICO Single Use Negative Pressure Wound Therapy System
K172519 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 25d
Cleared Sep 15, 2017
Mazor X
K172522 · OLO
Mazor Robotics , Ltd.
Orthopedic · 25d
Cleared Sep 14, 2017
BePOD® Foot Screws
K163148 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 309d
Cleared Sep 14, 2017
Fiagon Navigation System
K163209 · HAW
Fiagon GmbH
Neurology · 303d
Cleared Sep 14, 2017
MediClear PreOp
K163556 · KKX
Covalontechnologies, Inc.
General Hospital · 269d
Cleared Sep 14, 2017
Shotel Ankle Arthrodesis Nail System
K163627 · HSB
Biopro, Inc.
Orthopedic · 266d
Cleared Sep 14, 2017
Masimo Rad-97 and Accessories
K170168 · MWI
Masimo Corporation
Cardiovascular · 238d
Cleared Sep 14, 2017
Entuit Start Initial Placement Gastrostomy Set
K170323 · KGC
Cook Incorporated
Gastroenterology & Urology · 225d
Cleared Sep 14, 2017
AirLife Adult Heated Wire BiPAP/NIV Circuit
K170378 · BZE
Vyaire Medical
Anesthesiology · 219d
Cleared Sep 14, 2017
VIPER PRIME navigated inserter
K170937 · OLO
Medos International SARL
Orthopedic · 168d