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
122041–122064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 17, 1991
CHAMPION, BEHIND-THE-EAR HEARING AID
K911705 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
MODEL 800, BEHIND-THE-EAR HEARING AID
K911706 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
REGAL, BEHIND-THE-EAR HEARING AID
K911707 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
MODEL E-50, IN-THE-EAR HEARING AID
K911708 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
STOCK CANAL, IN-THE-EAR HEARING AID
K911709 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 16, 1991
XEMEX TEMPORARY PACING CATHETER A
K904868 · LDF
Zeon Medical Corp.
Cardiovascular · 199d
Cleared May 16, 1991
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
K905824 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 136d
Cleared May 16, 1991
RMI VASCULAR TOURNIQUET KIT
K910221 · DXC
Research Medical, Inc.
Cardiovascular · 119d
Cleared May 16, 1991
WARMAIR SYSTEM
K910327 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 111d
Cleared May 16, 1991
CORDIS PEEL-AWAY INSERTION TOOL
K910688 · DYB
Cordis Corp.
Cardiovascular · 86d