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
40129–40152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2013
JONES-FX FRACTURE SYSTEM
K131620 · HWC
Instratek, Inc.
Orthopedic · 52d
Cleared Jul 25, 2013
SENSIS, SENSIS LITE
K131812 · DQK
Siemens Medi Cal Solutions, Inc.
Cardiovascular · 36d
Cleared Jul 25, 2013
HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)
K131974 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 27d
Cleared Jul 24, 2013
EDWARDS EMBOL-X INTRODUCER SHEATH
K123714 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 232d
Cleared Jul 24, 2013
MTA CEMENTS
K130125 · KIF
S&C Polymer Silicon- Und Composite...
Dental · 188d
Cleared Jul 24, 2013
LINA BIPOLAR LOOP
K130305 · HIN
Lina Medical Aps
Obstetrics & Gynecology · 169d
Cleared Jul 24, 2013
POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL
K130667 · LYY
Preventive Care, Inc.
General Hospital · 134d
Cleared Jul 24, 2013
R&D 5D RETIC HEMATOLOGY CONTROL
K130962 · JPK
R&D Systems, Inc.
Hematology · 107d
Cleared Jul 24, 2013
XPERGUIDE
K131263 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 82d
Cleared Jul 24, 2013
REFORM PEDICLE SCREW SYSTEM
K131343 · MNI
Spinal USA
Orthopedic · 76d
Cleared Jul 24, 2013
NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC
K131542 · FRO
Novabay Pharmaceuticals, Inc.
General & Plastic Surgery · 56d
Cleared Jul 24, 2013
SAM JUNCTIONAL TOURNIQUET
K131561 · DXC
Sam Medical Products
Cardiovascular · 55d
Cleared Jul 24, 2013
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K131690 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 44d
Cleared Jul 24, 2013
HEM-6131
K131742 · DXN
Omron Healthcare, Inc.
Cardiovascular · 41d
Cleared Jul 24, 2013
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
K131964 · DWA
Medtronic, Inc.
Cardiovascular · 27d
Cleared Jul 24, 2013
PERCUNAV SYSTEM
K132087 · JAK
Philips Health Care
Radiology · 19d
Cleared Jul 23, 2013
MFP-051
K123631 · EBF
GC America, Inc.
Dental · 242d
Cleared Jul 23, 2013
SHARPSCAN
K123807 · MMK
Medical Engineering Development...
General Hospital · 224d
Cleared Jul 23, 2013
SPACELABS HEALTHCARE CARDIOEXPRESS
K130207 · DPS
Spacelabs Healthcare, Ltd.
Cardiovascular · 176d
Cleared Jul 23, 2013
FORUM GLAUCOMA WORKPLACE
K130648 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 134d
Cleared Jul 23, 2013
AIRSONETT AIR-4
K130702 · FRF
Airsonett AB
General Hospital · 130d
Cleared Jul 23, 2013
NIGHTINGALE MONITORING SYSTEM
K130740 · MWI
Zoe Medical, Inc.
Cardiovascular · 126d
Cleared Jul 23, 2013
CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM
K130862 · ELC
Dentsply Intl., Inc.
Dental · 117d
Cleared Jul 23, 2013
FRAG-LOC SYSTEM
K130986 · HTN
Acumed, LLC
Orthopedic · 105d