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
12985–13008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2022
Joule diVa System
K213761 · GEX
Sciton, Inc
General & Plastic Surgery · 230d
Cleared Jul 19, 2022
Surgical face mask
K220777 · FXX
Hubei Qianjiang Kingphar Medical...
General Hospital · 124d
Cleared Jul 19, 2022
BrainInsight
K220815 · QIH
Hyperfine, Inc.
Radiology · 120d
Cleared Jul 19, 2022
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy...
K220943 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 110d
Cleared Jul 19, 2022
Beauty LED Mask, Model: KFB265
K221151 · OHS
Hunan Guangye Biotechnology Co., Ltd.
General & Plastic Surgery · 90d
Cleared Jul 19, 2022
ARTIS icono (Ceiling Configuration)
K221516 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Jul 19, 2022
Selectra Lead Implantation System
K222037 · DQY
Biotronik, Inc.
Cardiovascular · 8d
Cleared Jul 18, 2022
KLS Martin Individual Patient Solutions
K210731 · JEY
KLS-Martin L.P.
Dental · 494d
Cleared Jul 18, 2022
Planmed Clarity 2D, Planmed Clarify S
K211720 · MUE
Planmed OY
Radiology · 409d
Cleared Jul 18, 2022
OSSIX Breeze
K212509 · NPL
Datum Dental, Ltd.
Dental · 343d
Cleared Jul 18, 2022
Ultrasonic Scalpel System
K212614 · LFL
Surgnova Healthcare Technologies...
General & Plastic Surgery · 334d
Cleared Jul 18, 2022
Vivid T8, Vivid T9
K221147 · IYN
GE Medical Systems Ultrasound and...
Radiology · 89d
Cleared Jul 18, 2022
Vivid iq
K221148 · IYN
GE Medical Systems Ultrasound &...
Radiology · 89d
Cleared Jul 18, 2022
PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.
K221803 · IZL
Sedecal., Sa.
Radiology · 26d
Cleared Jul 16, 2022
0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub
K213955 · QTI
Becton, Dickinson and Company
General Hospital · 211d
Cleared Jul 16, 2022
Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder...
K221229 · LZA
Zibo Blue Sail Health Technology Co.,...
General Hospital · 78d
Cleared Jul 15, 2022
Nerve Tape
K210665 · JXI
Biocircuit Technologies, Incorporated
Neurology · 497d
Cleared Jul 15, 2022
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No....
K212778 · QLX
Abbott Molecular, Inc.
Microbiology · 317d
Cleared Jul 15, 2022
ers2 - ergoline Rehabilitation System
K212883 · DRG
Ergoline GmbH
Cardiovascular · 308d
Cleared Jul 15, 2022
Tatum Surgical Dental Implant System
K213576 · DZE
Suncoast Dental, Inc. Dba Tatum Surgical
Dental · 247d
Cleared Jul 15, 2022
ComPAS2
K213872 · BZG
Morgan Scientific, Inc.
Anesthesiology · 214d
Cleared Jul 15, 2022
Kontact Dental Implant System
K213997 · DZE
Biotech Dental, Sas
Dental · 206d
Cleared Jul 15, 2022
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar,...
K220127 · OBP
Neuronetics, Inc.
Neurology · 178d
Cleared Jul 15, 2022
Vivid S60N, Vivid S70N
K220619 · IYN
GE Medical Systems Ultrasound and...
Radiology · 134d