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
10249–10272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2023
ArtiSential Laparoscopic Instruments-Electrodes
K230499 · GEI
Livsmed, Inc.
General & Plastic Surgery · 61d
Cleared Apr 26, 2023
MR DWI/FLAIR Measurement V1.0
K230552 · LLZ
Olea Medical
Radiology · 57d
Cleared Apr 26, 2023
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
K230553 · MXD
Medtronic, Inc.
Cardiovascular · 57d
Cleared Apr 26, 2023
TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
K230829 · NUH
Chongqing Rob Linka Science and...
Neurology · 30d
Cleared Apr 25, 2023
NITRO Interbody Fusion Cage System Family
K220513 · ODP
Ctl Medical Corporation
Orthopedic · 427d
Cleared Apr 25, 2023
Ceevra Reveal 3
K222676 · QIH
Ceevra, Inc.
Radiology · 231d
Cleared Apr 25, 2023
Wallaby 017 Micro Catheter
K223139 · KRA
Wallaby Medical
Neurology · 203d
Cleared Apr 25, 2023
MiVu™ Esophageal Endo Cap
K230056 · QIS
Diversatek Healthcare
Gastroenterology & Urology · 106d
Cleared Apr 25, 2023
TMINI™ Miniature Robotic System
K230202 · OLO
THINK Surgical, Inc.
Orthopedic · 90d
Cleared Apr 25, 2023
ALPHALOK Plating System
K230204 · HRS
Vilex, LLC
Orthopedic · 90d
Cleared Apr 25, 2023
DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
K230218 · NHA
Dental Direkt GmbH
Dental · 89d
Cleared Apr 25, 2023
iCAC Device
K230223 · JAK
Bunkerhill, Inc.
Radiology · 89d
Cleared Apr 25, 2023
Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable
K230503 · DRF
Boston Scientific
Cardiovascular · 60d
Cleared Apr 25, 2023
IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL,...
K230549 · OHT
Shenzhen Xiazhifeng Electronic Co., Ltd.
General & Plastic Surgery · 56d
Cleared Apr 25, 2023
Tigereye ST CTO-Crossing Catheter
K230594 · PDU
Avinger, Inc.
Cardiovascular · 53d
Cleared Apr 25, 2023
Konicaminolta DI-X1
K230906 · LLZ
Konica Minolta, Inc.
Radiology · 25d
Cleared Apr 24, 2023
NEST-C Interbody System
K220261 · ODP
Paonan Biotech Co., Ltd.
Orthopedic · 448d
Cleared Apr 24, 2023
Kisar Stratford SI Screw System
K220274 · OUR
Anjali Investments L.L.C
Orthopedic · 448d
Cleared Apr 24, 2023
The Heart Seat
K222330 · MWI
Casana Care, Inc.
Cardiovascular · 265d
Cleared Apr 24, 2023
SmartGUIDE deflectable hydrophilic guidewire
K222690 · MOF
Artiria Medical SA
Neurology · 230d
Cleared Apr 24, 2023
STR8 Clear Aligner
K223141 · NXC
Str8 Oral Care
Dental · 202d
Cleared Apr 24, 2023
Omnipod GO Insulin Delivery Device
K223372 · LZG
Insulet Corporation
Chemistry · 171d
Cleared Apr 24, 2023
Klockner Abutments
K230103 · NHA
SOADCO, S.L.
Dental · 101d
Cleared Apr 24, 2023
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
K230136 · MWP
Compai Healthcare (Suzhou) Co.,Ltd
Radiology · 96d