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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
69145–69168 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2003
CERABIEN ZR
K031968 · EIH
Noritake Co., Inc.
Dental · 179d
Cleared Dec 22, 2003
B&R DEVICE
K032925 · EGS
Ronvig A/S
Dental · 91d
Cleared Dec 22, 2003
RH-950
K033192 · KTB
Iomed, Inc.
Physical Medicine · 81d
Cleared Dec 22, 2003
EPRICORD
K033267 · EBF
Kuraray Medical, Inc.
Dental · 74d
Cleared Dec 22, 2003
VINYL EXAMINATION GLOVES, POWDERED
K033308 · LYZ
Tangshan Transocean Plastic Products...
General Hospital · 69d
Cleared Dec 22, 2003
CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY...
K033394 · FGE
Cordis Corp.
Gastroenterology & Urology · 60d
Cleared Dec 22, 2003
MESACUP-2 TEST JO-1, MODEL 10756
K033528 · LLL
Rhigene, Inc.
Immunology · 45d
Cleared Dec 22, 2003
VERSYO.BOND
K033629 · EBI
Heraeus Kulzer, Inc.
Dental · 33d
Cleared Dec 22, 2003
CLINICAL LASETTE P-200
K033799 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 17d
Cleared Dec 19, 2003
BAY AREA HYPERSCIENCES
K030713 · CBF
Bay Area Hypersciences, LLC
Anesthesiology · 288d
Cleared Dec 19, 2003
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES...
K031260 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 242d
Cleared Dec 19, 2003
IXL DIABETES MANAGEMENT SYSTEM
K031373 · LZG
Insulet Corp.
General Hospital · 233d
Cleared Dec 19, 2003
MEDISCOPE
K031436 · HEX
Sometech Corporation
Obstetrics & Gynecology · 227d
Cleared Dec 19, 2003
INSTAREAD LITHIUM SYSTEM
K031579 · JIH
Akers Laboratories, Inc.
Toxicology · 213d
Cleared Dec 19, 2003
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
K031831 · HKO
Topcon Medical Systems, Inc.
Ophthalmic · 189d
Cleared Dec 19, 2003
BAYER CLINITEK STATUS ANALYZER
K031947 · KQO
Bayer Healthcare, LLC
Chemistry · 178d
Cleared Dec 19, 2003
REVOLUTION SPINAL FIXATION SYSTEM
K032219 · MNI
Spinal Innovations, Inc.
Orthopedic · 151d
Cleared Dec 19, 2003
IMMUNETECH TOTAL IGE SYSTEM
K032251 · DGC
Immunetech Corporation
Immunology · 150d
Cleared Dec 19, 2003
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
K032288 · MQV
Orthovita, Inc.
Orthopedic · 148d
Cleared Dec 19, 2003
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH...
K032663 · DCK
Instrumentation Laboratory CO
Chemistry · 113d
Cleared Dec 19, 2003
VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
K032763 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 105d
Cleared Dec 19, 2003
PHENOL RED STOCK SOLUTION
K032887 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 94d
Cleared Dec 19, 2003
SHELHIGH NO-REACT BIOCUFF
K032893 · FTL
Shelhigh, Inc.
General & Plastic Surgery · 93d
Cleared Dec 19, 2003
MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1
K032928 · GZJ
Mediphysics Pain Centers of America
Neurology · 88d