Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
164857–164880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1981
SARA
K810585 · CBS
Allied Healthcare Products, Inc.
Anesthesiology · 20d
Cleared Mar 24, 1981
EMIT-TFG PRISMA THYROXINE CALIBRATORS
K810587 · JIS
Syva Co.
Chemistry · 20d
Cleared Mar 24, 1981
CRYSTALLOY-P
K810594 · EJH
Shofu Dental Corp.
Dental · 18d
Cleared Mar 24, 1981
SILUX RESTORATIVE MATERIAL & ENAMEL BOND
K810595 · EBF
3M Company
Dental · 18d
Cleared Mar 24, 1981
CAPD EXCHANGE SET
K810600 · KDJ
American Mcgaw
Gastroenterology & Urology · 18d
Cleared Mar 24, 1981
FULCAST/SUMMIT CASTING ALLOY
K810611 · EJH
C.Vaupel Dental, Inc.
Dental · 18d
Cleared Mar 24, 1981
HOFFMAN HOOP DEVICE
K810644
Howmedica Corp.
Orthopedic · 14d
Cleared Mar 24, 1981
CCPD CYCLER SET
K810670 · KDJ
American Medical Products, Inc.
Gastroenterology & Urology · 12d
Cleared Mar 24, 1981
CCPD 3 LITER DRAINAGE SET
K810671 · KDJ
American Medical Products, Inc.
Gastroenterology & Urology · 12d
Cleared Mar 24, 1981
ELECTRONIC SPIROMETER MODEL MFR-8100
K810712 · BTY
Nihon Kohden America, Inc.
Anesthesiology · 7d
Cleared Mar 23, 1981
FUNGIZONE
K810784 · KIT
Dutchland Laboratories, Inc.
Chemistry
Cleared Mar 20, 1981
CYBER 120 HEMODIALYZER
K802478 · FJG
Cyberex Corp.
Gastroenterology & Urology · 169d
Cleared Mar 20, 1981
TRANSCUTANEOUS ELECT. NERVE STIMULATOR
K803247
Medical Research Laboratories, Inc.
Neurology · 87d
Cleared Mar 20, 1981
NEO NATAL RESPIRATION FUNCTION BLOCK
K810175 · BZQ
Honeywell, Inc.
Anesthesiology · 57d
Cleared Mar 20, 1981
AUTO SUTURE PSS SKIN STAPLING INSTRUMENT
K810187 · KBC
United States Surgical, A Division of...
Ear, Nose, Throat · 57d
Cleared Mar 20, 1981
AUTO SUTURE GAS POWERED DISP. LDS STAPL
K810188 · KBC
United States Surgical, A Division of...
Ear, Nose, Throat · 57d
Cleared Mar 20, 1981
TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG
K810193 · HAX
Ace Orthopedic Manufacturing Co.
Neurology · 56d
Cleared Mar 20, 1981
DUAL TYPE ELECTRODE
K810206 · GXY
Professional Instruments Co.
Neurology · 53d
Cleared Mar 20, 1981
MSI BONE MARROW BIOPSY NEEDLE W/J TIP
K810248 · GAA
Creative Research and Mfg., Inc.
General & Plastic Surgery · 50d
Cleared Mar 20, 1981
COMPUTER INTERFACE MODULE
K810295 · FRN
Y
General Hospital · 44d
Cleared Mar 20, 1981
ALTERNATE STERILIZ. FOR CELLULOSE ACET
K810315 · FKQ
Cordis Corp.
Gastroenterology & Urology · 43d
Cleared Mar 20, 1981
AUTOMATIC HEMOCLIP APPLIER, 527700
K810324 · GDW
Edward Weck, Inc.
General & Plastic Surgery · 42d
Cleared Mar 20, 1981
DUO-TEL
K810331 · DRG
General Electric Co.
Cardiovascular · 39d
Cleared Mar 20, 1981
RESPIRIZER
K810335 · KFZ
Respirizer Co., Div. Campillary...
Anesthesiology · 39d