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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
120289–120312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1991
STANDARD S32
K912308 · EJS
Metalor Dental USA Corp.
Dental · 80d
Cleared Aug 09, 1991
SOLCHROM-PAL
K912313 · EJT
Metalor Dental USA Corp.
Dental · 80d
Cleared Aug 09, 1991
MOBILE X-RAY FLOOR STAND
K912400 · IZL
Dntl Corp.
Radiology · 71d
Cleared Aug 09, 1991
PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT
K912428 · CBZ
Puritan Bennett Corp.
Anesthesiology · 70d
Cleared Aug 09, 1991
MOTOR MASSAGE PILLOW
K912479 · IRO
Supreme Import , Ltd.
Physical Medicine · 67d
Cleared Aug 09, 1991
INSIDE JOB
K912871 · HRX
3M Health Care, Ltd.
Orthopedic · 42d
Cleared Aug 09, 1991
BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
K913270 · JOH
Bivona Medical Technologies
Anesthesiology · 17d
Cleared Aug 09, 1991
VITAL-PORT(R) PETITE VASCULAR ACCESS SYSTEM
K913350 · LJT
Med Institute, Inc.
General Hospital · 14d
Cleared Aug 07, 1991
FLEXIFLO ENTERAL FEEDING TUBE
K910382 · KNT
Abbott Laboratories
Gastroenterology & Urology · 190d
Cleared Aug 07, 1991
TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET
K910558 · FJK
Terumo Medical Corp.
Gastroenterology & Urology · 180d
Cleared Aug 07, 1991
TREATMENT TABLE
K910838 · IXR
Tri W-G, Inc.
Radiology · 161d
Cleared Aug 07, 1991
DIGITAL SPHYGMOIMANOMETER, MODEL UA-830
K911049 · DXN
A&D Engineering, Inc.
Cardiovascular · 152d
Cleared Aug 07, 1991
PR4
K911097 · DSH
Mortara Instrument, Inc.
Cardiovascular · 148d
Cleared Aug 07, 1991
SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION
K911105 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 148d
Cleared Aug 07, 1991
MMG BILE BAG
K911129 · EXF
Medical Technologies of Georgia
Gastroenterology & Urology · 146d
Cleared Aug 07, 1991
OVAL CUP BIOPSY FORCEP
K911155 · FCF
Endovations
Gastroenterology & Urology · 145d
Cleared Aug 07, 1991
CUFFABLE
K911213 · DXQ
Biomedical Dynamics, Inc.
Cardiovascular · 141d
Cleared Aug 07, 1991
IDEIA(TM) CHLAMYDIA, MODIFICATION
K911430 · LIC
Novo Nordisk Diagnostics, Ltd.
Microbiology · 132d
Cleared Aug 07, 1991
HEMOSPAL KIT B22
K911603 · KDI
C.G.H. Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Aug 07, 1991
MITRASHEER TRANSPLANT DRESSING
K911649 · MGP
Polymint Industrial Co. , Ltd.
General & Plastic Surgery · 117d
Cleared Aug 07, 1991
FMA TRANSLATOR
K912086 · BXB
Normandie Group, Inc.
Physical Medicine · 86d
Cleared Aug 07, 1991
DIGITAL SPHYGMOMANOMETER MODEL UA-833
K912118 · DXN
A&D Engineering, Inc.
Cardiovascular · 85d
Cleared Aug 07, 1991
DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 212
K912119 · DXN
A&D Engineering, Inc.
Cardiovascular · 85d
Cleared Aug 07, 1991
URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
K912120 · FBN
Olympus Corp.
Gastroenterology & Urology · 85d