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
20689–20712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2020
Atlantis suprastructures
K193064 · NHA
Dentsply Sirona, Inc.
Dental · 120d
Cleared Mar 03, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx)...
K193358 · LTT
Beckman Coulter, Inc.
Microbiology · 90d
Cleared Mar 03, 2020
OVision Imaging System
K200275 · NFJ
Ophthalmic Labs, Inc.
Ophthalmic · 28d
Cleared Mar 02, 2020
CARDIOVIT AT-102 G2
K183425 · DPS
Schiller AG
Cardiovascular · 447d
Cleared Mar 02, 2020
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
K191872 · LPN
Menicon Co, Ltd.
Ophthalmic · 234d
Cleared Mar 02, 2020
Vantage Galan 3T, MRT-3020, V6.0
K192506 · LNH
Canon Medical Systems Corporation
Radiology · 172d
Cleared Mar 02, 2020
High Strength Suture
K192637 · GAT
Yunyi (Beijing) Medical Device Co., Ltd.
General & Plastic Surgery · 160d
Cleared Mar 02, 2020
Anjon Bremer Halo System
K193256 · JEC
Anjon Holdings, LLC
Orthopedic · 97d
Cleared Mar 02, 2020
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
K193356 · GEI
Covidien, LLC
Ear, Nose, Throat · 89d
Cleared Mar 02, 2020
CarboClear Lumbar Cage System
K193378 · MAX
CarboFix Orthopedics , Ltd.
Orthopedic · 88d
Cleared Mar 02, 2020
LIAISON Anti-HAV Assay
K193532 · LOL
DiaSorin, Inc.
Microbiology · 73d
Cleared Feb 29, 2020
Kingon P2 Oxygen Concentrator
K190304 · CAW
Qingdao Kingon Medical Science and...
Anesthesiology · 382d
Cleared Feb 28, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183680 · JPI
Abbott Point of Care, Inc.
Hematology · 427d
Cleared Feb 28, 2020
Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)
K191246 · DTZ
Chalice Medical , Ltd.
Cardiovascular · 295d
Cleared Feb 28, 2020
HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length
K191555 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 261d
Cleared Feb 28, 2020
Red Dot
K191556 · QFM
Behold.Ai Technologies Limited
Radiology · 261d
Cleared Feb 28, 2020
AccuContour
K191928 · QKB
Xiamen Manteia Technology , Ltd.
Radiology · 224d
Cleared Feb 28, 2020
Steripath Gen2 Blood Collection System
K192247 · JKA
Magnolia Medical Technologies, Inc.
General Hospital · 193d
Cleared Feb 28, 2020
scaffolene CL100 Bioresorbable Collagen Matrix
K192346 · KGN
Freudenberg Technology Innovation SE...
General & Plastic Surgery · 183d
Cleared Feb 28, 2020
Superelastic Staple
K192447 · JDR
Neosteo
Orthopedic · 175d
Cleared Feb 28, 2020
Magnetom Sola, Magnetom Altea and Magnetom Sola Fit
K192496 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 170d
Cleared Feb 28, 2020
Atlas Spine Expandable Cervical Standalone Interbody System
K192570 · OVE
Atlas Spine, Inc.
Orthopedic · 163d
Cleared Feb 28, 2020
Zimmer M/L Taper Hip Prosthesis
K192660 · LZO
Zimmer, Inc.
Orthopedic · 156d
Cleared Feb 28, 2020
SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use...
K192820 · KGO
Medline Industries, Inc.
General Hospital · 150d