FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
122017–122040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1991
MILENIA PROGESTERONE
K911512 · JLS
Diagnostic Products Corp.
Chemistry · 48d
Cleared May 22, 1991
CATHCAP, CAT. NO. CC100 SERIES
K911519 · DQY
Gish Biomedical, Inc.
Cardiovascular · 48d
Cleared May 22, 1991
ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION
K911724 · DIF
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 35d
Cleared May 22, 1991
CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE
K911755 · JJY
Bionostics, Inc.
Chemistry · 34d
Cleared May 22, 1991
SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN.
K911766 · HQY
Gall'S, Inc.
Ophthalmic · 33d
Cleared May 21, 1991
WHEELCHAIR CONVERSION KIT
K904650 · ITI
Hadco Marketing Services, Inc.
Physical Medicine · 231d
Cleared May 21, 1991
AUTOMASTER
K904934 · IPQ
Team Mfg., Inc.
Physical Medicine · 201d
Cleared May 21, 1991
S-ROM OBLONG ACETABULAR CUP
K905258 · JDI
Joint Medical Products Corp.
Orthopedic · 181d
Cleared May 21, 1991
HALE SUN SURGICAL TOWEL OR O.R. TOWEL
K905803 · KKX
Hale Sun Industries, Ltd.
General Hospital · 144d
Cleared May 21, 1991
TARGET ASO TEST
K910073 · GTQ
Texas Immunology, Inc.
Microbiology · 132d
Cleared May 21, 1991
WALLACH COLD SOAKER
K910491 · GEH
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 105d
Cleared May 21, 1991
RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE
K910708 · IMI
Rich-Mar Corp.
Physical Medicine · 90d
Cleared May 21, 1991
VILLAN (VIDEO LIFT LINK ANALYSIS)
K910712 · LXI
Physio Systems, Inc.
Orthopedic · 90d
Cleared May 21, 1991
JACKSON MULTIPURPOSE OPERATING TABLE
K910736 · JEA
Orthopedic Systems, Inc.
General & Plastic Surgery · 89d
Cleared May 21, 1991
ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012
K910845 · DTL
Interventional Therapeutics Corp.
Cardiovascular · 83d
Cleared May 21, 1991
EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP
K911289 · FRN
Baxter Healthcare Corp
General Hospital · 57d
Cleared May 21, 1991
CELL SWEEP
K911327 · HHT
Reza S Mohajer, M.D. C/O Krass & Young
Obstetrics & Gynecology · 56d
Cleared May 21, 1991
REDDICK TROCAR AND CANNULA
K911601 · FSM
Ideal Medical, Inc.
General & Plastic Surgery · 41d
Cleared May 21, 1991
MEDI GUARD DRAPES
K911950 · KME
Sancella, Inc.
General Hospital · 20d
Cleared May 20, 1991
ENZYGNOST ANTI-CMV/IGG + IGM
K901485 · LFZ
Behring Diagnostics, Inc.
Microbiology · 417d
Cleared May 20, 1991
ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY
K904253 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 248d
Cleared May 20, 1991
FRANKLIN 9000 WALL STAND
K905789 · KPX
Mallinckrodt Group, Inc.
Radiology · 144d
Cleared May 20, 1991
EPINEPHRINE REAGENT, CAT. NO. 5367
K910680 · GHR
Helena Laboratories
Hematology · 94d
Cleared May 20, 1991
COLLAGEN REAGENT CAT. NO. 5368
K910706 · GHR
Helena Laboratories
Hematology · 89d