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
13081–13104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 2022
IPL Hair Remover, Model: G993, G996, G998 and G885
K221679 · OHT
Shenzhen Mywin Technology Co., Ltd.
General & Plastic Surgery · 28d
Cleared Jul 06, 2022
Minuteful - kidney test
K210069 · JIR
Healthy.Io, Ltd.
Chemistry · 541d
Cleared Jul 06, 2022
My3D® Personalized Pelvic Reconstruction
K212815 · LPH
Onkos Surgical
Orthopedic · 306d
Cleared Jul 06, 2022
Disposable Biopsy Refill Needle
K212819 · FCG
Suzhou Leapmed Healthcare Corporation
General & Plastic Surgery · 306d
Cleared Jul 06, 2022
Disposable Semi Automatic Biopsy Instrument
K212820 · KNW
Suzhou Leapmed Healthcare Corporation
General & Plastic Surgery · 306d
Cleared Jul 06, 2022
Disposable Coaxial Biopsy Needle
K212822 · FCG
Suzhou Leapmed Healthcare Corporation
General & Plastic Surgery · 306d
Cleared Jul 06, 2022
Cerebra Sleep System
K213007 · OLV
Cerebra Medical , Ltd.
Neurology · 289d
Cleared Jul 06, 2022
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
K213822 · OCC
Roche Molecular Systems, Inc.
Microbiology · 210d
Cleared Jul 06, 2022
Oscar Peripheral Multifunctional Catheter system
K214038 · LIT
Biotronik, Inc.
Cardiovascular · 195d
Cleared Jul 06, 2022
ChoiceSpine Navigation System
K220024 · OLO
Choice Spine, LLC
Orthopedic · 182d
Cleared Jul 06, 2022
Lancet (I, II, III, V, VI)
K220475 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 138d
Cleared Jul 06, 2022
SURGIVISIO Device
K221028 · OLO
Ecential Robotics
Orthopedic · 90d
Cleared Jul 06, 2022
UniPrime A, UniPrime E, UniPrime E/C
K221033 · KLE
S&C Polymer Silicon- Und Composite...
Dental · 90d
Cleared Jul 06, 2022
Surgical Mask (Model: 0868F, 0866F)
K221173 · FXX
Jiangxi Sanhao Medical Instruments...
General Hospital · 72d
Cleared Jul 06, 2022
Functional MR V1.0
K221426 · LLZ
Olea Medical S.A.S.
Radiology · 51d
Cleared Jul 05, 2022
SleepCheckRx
K213360 · MNR
Resapp Health
Anesthesiology · 266d
Cleared Jul 05, 2022
CediTEC
K220743 · EBI
Voco GmbH
Dental · 113d
Cleared Jul 05, 2022
Electric Wheelchair
K220827 · ITI
Foshan Dahao Medical Technology Co.,...
Physical Medicine · 105d
Cleared Jul 05, 2022
Osteon Precision Milled Suprastructure
K221019 · NHA
Implant Solutions Pty Ltd (Aka Osteon...
Dental · 90d
Cleared Jul 05, 2022
Materialise TKA Guide System
K221337 · JWH
Materialise NV
Orthopedic · 57d
Cleared Jul 01, 2022
Hanger Cranial Band 3D
K203134 · MVA
Symbion Logistics, LLC
Neurology · 620d
Cleared Jul 01, 2022
BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
K211085 · BSP
Becton, Dickinson and Company
Anesthesiology · 445d
Cleared Jul 01, 2022
Dental diode laser, SOGA Laser, ILaser II
K211150 · NVK
Shenzhen Soga Technology Co., Ltd.
Dental · 438d
Cleared Jul 01, 2022
Smith & Nephew Hip Systems
K211176 · LPH
Smith & Nephew, Inc.
Orthopedic · 437d