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
10633–10656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 2023
UniCam Evo Software
K230393 · LLZ
Inter Medical Medizintechnik GmbH
Radiology · 58d
Cleared Apr 13, 2023
Symmed Elite Aesthetic
K230412 · PBX
Termosalud
General & Plastic Surgery · 57d
Cleared Apr 13, 2023
NaviCam Xpress Stomach System, NaviCam Xpress System
K230694 · QKZ
Anx Robotica Corp
Gastroenterology & Urology · 31d
Cleared Apr 13, 2023
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
K230719 · QOF
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Apr 13, 2023
SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE®...
K230868 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 15d
Cleared Apr 12, 2023
Polyfusion IV Administration Sets
K220312 · FPA
Poly Medicure Limited
General Hospital · 434d
Cleared Apr 12, 2023
Task Force CORE
K223332 · DXN
Cnsystems Medizintechnik GmbH
Cardiovascular · 163d
Cleared Apr 12, 2023
Catalys™ Precision Laser System
K223838 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 111d
Cleared Apr 12, 2023
Omnia Medical Coupler-A™ Anterior Lumbar Plate System
K230424 · KWQ
Omnia Medical, LLC
Orthopedic · 54d
Cleared Apr 11, 2023
Neuspera Nuity System
K221303 · GZF
Neuspera Medical, Inc.
Neurology · 341d
Cleared Apr 11, 2023
Augmento
K222781 · LLZ
Deeptek Medical Imaging Private Limited
Radiology · 208d
Cleared Apr 11, 2023
Bronchoscope System
K222910 · EOQ
Shenzhen HugeMed Medical Technical...
Ear, Nose, Throat · 197d
Cleared Apr 11, 2023
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
K223530 · NRY
Route 92 Medical, Inc.
Neurology · 139d
Cleared Apr 11, 2023
ZeptoLink IOL Positioning System
K223763 · PUL
Centricity Vision, Inc.
Ophthalmic · 117d
Cleared Apr 11, 2023
Ultrasound System 2300
K223830 · IYN
Bk Medical Aps
Radiology · 111d
Cleared Apr 11, 2023
ENROUTE® Transcarotid Neuroprotection System
K230402 · NTE
Silk Road Medical
Cardiovascular · 55d
Cleared Apr 11, 2023
POT PTCA Balloon Dilatation Catheter
K230705 · LOX
Brosmed Medical Co., Ltd.
Cardiovascular · 28d
Cleared Apr 11, 2023
Eagle S/Saevo Slim/D700 Slim
K230732 · MUH
Alliage S/A Industrias Medica...
Radiology · 26d
Cleared Apr 11, 2023
RCT800
K230753 · OAS
Ray Co., Ltd.
Radiology · 25d
Cleared Apr 11, 2023
L12 LED Light Source with AIM
K230754 · OWN
Stryker
General & Plastic Surgery · 25d
Cleared Apr 10, 2023
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
K222887 · DXN
Famidoc Technology Company Limited
Cardiovascular · 199d
Cleared Apr 10, 2023
Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner...
K223176 · KRA
Argon Medical Devices, Inc.
Cardiovascular · 181d
Cleared Apr 10, 2023
DMX
K223550 · KPR
Del Medical, Inc.
Radiology · 136d
Cleared Apr 10, 2023
IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
K230122 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 83d