FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
10225–10248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 2023
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
K222885 · LPL
Pegavision Corporation
Ophthalmic · 250d
Cleared May 31, 2023
Nihon Kohden NKV-440 Ventilator System
K222644 · CBK
Nihon Kohden Orangemed, Inc.
Anesthesiology · 272d
Cleared May 31, 2023
BTL-785X
K222556 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 281d
Cleared May 31, 2023
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable...
K221067 · NLH
Surgical Instrument Service and...
Cardiovascular · 414d
Cleared May 31, 2023
CombiSet Hemodialysis Blood Tubing Set
K213992 · FJK
Fresenius Medical Care Renal...
Gastroenterology & Urology · 526d
Cleared May 31, 2023
FEELject LDV (Low dead volume) syringe
K213010 · QNQ
Feeltech Co., Ltd.
General Hospital · 618d
Cleared May 31, 2023
Oxus Sieve Beds
K211056 · CAW
Oxus, Inc.
Anesthesiology · 782d
Cleared May 30, 2023
First Glove Blue Nitrile Examination Gloves Powder Free
K230958 · LZA
First Glove Sdn. Bhd.
General Hospital · 56d
Cleared May 30, 2023
EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
K230909 · FCG
Cook Ireland, Ltd.
Gastroenterology & Urology · 60d
Cleared May 30, 2023
Victan
K230593 · GEI
Jiangsu Haize Medical Scientific...
General & Plastic Surgery · 88d
Cleared May 30, 2023
RFP-100A Connector Cable (Single Use)
K230571 · DSA
Baylis Medical Technologies, Inc.
Cardiovascular · 90d
Cleared May 30, 2023
Babyroo TN300
K230278 · FMT
Draeger Medical Systems, Inc.
General Hospital · 118d
Cleared May 30, 2023
Excipio SV Aspiration Catheter and Tubing
K230030 · QEW
Contego Medical, Inc.
Cardiovascular · 145d
Cleared May 30, 2023
KBA3D
K223841 · LLZ
S.M.A.I.O
Radiology · 159d
Cleared May 30, 2023
PrecisionTAVI (v1.1)
K223809 · QQI
Dasi Simulations
Cardiovascular · 161d
Cleared May 30, 2023
Smith & Nephew ACCORD™ Cable System
K223762 · HRS
Smith & Nephew
Orthopedic · 166d
Cleared May 30, 2023
Sonic DL
K223523 · LNH
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 188d
Cleared May 30, 2023
Quicktome Software Suite
K222359 · LLZ
Omniscient Neurotechnology Pty Ltd (O8t)
Radiology · 299d
Cleared May 30, 2023
Hydrozid Precise
K221897 · GEH
Bibawo Medical A/S
General & Plastic Surgery · 334d
Cleared May 30, 2023
MyPAO Guides
K220706 · PBF
Medacta International S.A.
Orthopedic · 446d
Cleared May 28, 2023
Blue Nitrile Examination Gloves Powder Free
K230601 · LZA
Latrile Gloves Private Limited
General Hospital · 86d
Cleared May 26, 2023
Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS
K231233 · JWH
Conformis, Inc.
Orthopedic · 28d
Cleared May 26, 2023
CD Horizon™ Spinal System
K231184 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 26, 2023
Kodiak Lumbar Spacer System
K230851 · MAX
Met One Technologies, LLC
Orthopedic · 59d