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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121441–121464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 20, 1991
ADP REAGENT
K910800 · GHR
Helena Laboratories
Hematology · 84d
Cleared May 20, 1991
MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING
K910908 · BSY
Vygon Corp.
Anesthesiology · 76d
Cleared May 20, 1991
MUCAID
K910909 · BSY
Vygon Corp.
Anesthesiology · 76d
Cleared May 20, 1991
HYGIENA-TRACH
K911080 · JOH
Apdyne Medical Co.
Anesthesiology · 70d
Cleared May 20, 1991
HYPODERMIC NEEDLES, SINGLE LUMEN
K911397 · FCG
Popper & Sons, Inc.
Gastroenterology & Urology · 52d
Cleared May 20, 1991
CPR BAG
K911622 · BTM
Merced Medical, Inc.
Anesthesiology · 39d
Cleared May 17, 1991
JUZO-RESPIRA ANTI-EMBOLISM STOCKING
K905413 · DWL
Julius Zorn, Inc.
General Hospital · 165d
Cleared May 17, 1991
ECAT SCANNER
K910048 · KPS
Cti Pet Systems, Inc.
Radiology · 130d
Cleared May 17, 1991
AUGUSTINE STYLET
K910659 · BSR
Augustine Medical, Inc.
Anesthesiology · 92d
Cleared May 17, 1991
ZINETICS INTERNAL REFERENCE PROBE
K910694 · FFT
Zinetics Medical, Inc.
Gastroenterology & Urology · 87d
Cleared May 17, 1991
CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING
K910791 · BSP
Kendall Healthcare Products Co....
Anesthesiology · 81d
Cleared May 17, 1991
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM
K910859 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared May 17, 1991
LATEX EXAM GLOVES-POWDER FREE
K910949 · LYY
Zhongmin (Fujian) Machinery &...
General Hospital · 92d
Cleared May 17, 1991
KODAK EKTASCAN CABLE EXTENSION
K911437 · LMC
Eastman Kodak Company
Radiology · 45d