FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
9937–9960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 2023
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
K230408 · JKA
Sb-Kawasumi Laboratories, Inc.
General Hospital · 106d
Cleared Jun 01, 2023
ANT-X System
K230185 · OWB
Ndr Medical Technology Pte. , Ltd.
Radiology · 129d
Cleared Jun 01, 2023
Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna...
K223929 · QEW
Innova Vascular, Inc.
Cardiovascular · 153d
Cleared Jun 01, 2023
SomniCheck
K223676 · GWL
Brainmatterz, LLC
Neurology · 175d
Cleared Jun 01, 2023
Brainomix 360 e-CTP
K223555 · LLZ
Brainomix Limited
Radiology · 185d
Cleared Jun 01, 2023
Radius VSM and Accessories
K223498 · MHX
Masimo Corporation
Cardiovascular · 192d
Cleared Jun 01, 2023
OmniTom Elite
K223447 · JAK
Neurologica Corporation, A Subsidiary...
Radiology · 198d
Cleared Jun 01, 2023
Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu®...
K223299 · EOQ
Ambu A/S
Ear, Nose, Throat · 217d
Cleared Jun 01, 2023
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps...
K222905 · MMK
Ningbo Maxcon Medical Technology Co.,...
General Hospital · 251d
Cleared May 31, 2023
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)
K231326 · MAI
Osteonic Co., Ltd.
Orthopedic · 23d
Cleared May 31, 2023
iRoot SP Plus
K231259 · KIF
Innovative Bioceramix, Inc.
Dental · 30d
Cleared May 31, 2023
Pitch PaSoft Tissue Reinforcement Device
K230671 · FTL
Xiros, Ltd.
General & Plastic Surgery · 82d
Cleared May 31, 2023
Disposable Nitrile Gloves (ABC-DG01)
K230542 · LZA
Huizhou Anboson Technology Co., Ltd.
General Hospital · 92d
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