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
22033–22056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2019
AccuCath Ace Intravascular Catheter
K191232 · FOZ
C.R. Bard, Inc.
General Hospital · 133d
Cleared Sep 18, 2019
Flexible HD Cysto-Urethroscope System
K191357 · FAJ
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 120d
Cleared Sep 18, 2019
HEDRON Lumbar Spacers
K191391 · MAX
Globus Medical, Inc.
Orthopedic · 117d
Cleared Sep 18, 2019
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602...
K191457 · PFO
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 110d
Cleared Sep 18, 2019
GM501 Mineral Oil
K191552 · MQL
Hamilton Thorne, Inc.
Obstetrics & Gynecology · 98d
Cleared Sep 18, 2019
Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0
K191663 · IYN
Canon Medical Systems Corporation
Radiology · 89d
Cleared Sep 18, 2019
Syngo.Via RT Image Suite
K192065 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Sep 18, 2019
InnoSight Diagnostic Ultrasound System
K192254 · IYN
Qisda Corporation
Radiology · 29d
Cleared Sep 17, 2019
Sapphire Dorsal Comfort Fit
K181416 · LRK
Crane Dental Laboratory, Inc.
Dental · 474d
Cleared Sep 17, 2019
Poly Clear
K183708 · OLP
Medtek Skincare, LLC
General & Plastic Surgery · 260d
Cleared Sep 17, 2019
Sim&Size
K190049 · PZO
Sim&Cure
Cardiovascular · 250d
Cleared Sep 17, 2019
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level...
K190308 · OXZ
Amd Medicom, Inc.
General Hospital · 217d
Cleared Sep 17, 2019
HEDRON Cervical Spacers
K191243 · ODP
Globus Medical, Inc.
Orthopedic · 131d
Cleared Sep 17, 2019
Reusable NIBP Cuff
K191253 · DXQ
Shenzhen Changke Connect Electronics...
Cardiovascular · 131d
Cleared Sep 17, 2019
iNSitu Bipolar Hip System
K191297 · KWY
Theken Companies, LLC
Orthopedic · 126d
Cleared Sep 17, 2019
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
K191842 · GEX
Quanta System Spa
General & Plastic Surgery · 70d
Cleared Sep 17, 2019
UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
K191929 · LPL
Unicon Optical Co., Ltd.
Ophthalmic · 60d
Cleared Sep 17, 2019
VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar...
K191947 · GEI
Maquet Cardiovascular, LLC
General & Plastic Surgery · 57d
Cleared Sep 17, 2019
Advisor VL Circular Mapping Catheter, Sensor Enabled
K192037 · DRF
Abbott Medical
Cardiovascular · 49d
Cleared Sep 17, 2019
Bio Guard Air/Water & Suction Valves
K192059 · ODC
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 47d
Cleared Sep 16, 2019
Full Automatic (NIBP) Blood Pressure Monitor
K190507 · DXN
Health & Life Co., Ltd.
Cardiovascular · 199d
Cleared Sep 16, 2019
AccelFix Lumbar Interbody Fusion Cage System
K190708 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 181d
Cleared Sep 16, 2019
Mercury® Spinal System, Overwatch® Spinal System
K191576 · NKB
Spinal Elements, Inc.
Orthopedic · 94d
Cleared Sep 16, 2019
AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle...
K191641 · HRS
Industrias Medicas Sampedro S.A.S
Orthopedic · 89d