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
163297–163320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1981
ELECTRO-SNAP
K812299 · GXY
Rodel Products Corp.
Neurology · 28d
Cleared Sep 11, 1981
PINCH METER
K812343 · HRW
Fred Sammons, Inc.
Neurology · 24d
Cleared Sep 11, 1981
HEEL OR ELBOW PROTECTOR
K812344 · FMP
Fred Sammons, Inc.
General Hospital · 24d
Cleared Sep 11, 1981
ARM SLINGS
K812345 · ILI
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Sep 11, 1981
ALUMINUM SCOOP DISK
K812346 · ILC
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Sep 11, 1981
RAISED CHAIR W/FOOT PLATFORM
K812347 · INN
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Sep 11, 1981
DESK ARM WHEELCHAIR ARM EXTENSION
K812348 · KNN
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Sep 11, 1981
HAND SPLINTS & COMPONENTS
K812349 · ILH
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Sep 11, 1981
WHEELCHAIR ACCESSORIES
K812350 · KNO
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Sep 09, 1981
PLASMA FLEX
K811523 · KSR
Terumo America, Inc.
Chemistry · 103d
Cleared Sep 09, 1981
SPIKE GUARD
K812130 · KDJ
Clinipad Corp.
Gastroenterology & Urology · 44d
Cleared Sep 09, 1981
MEDI VIEW
K812152 · IXC
Medical Synergy
Radiology · 42d
Cleared Sep 09, 1981
LIFE-TECH #1857 PRESSURE/POLOT MODULE
K812177 · EXQ
Life-Tech Instruments, Inc.
Gastroenterology & Urology · 37d
Cleared Sep 09, 1981
ANGIOSCAN SPECTRUM ANALYZER
K812184 · DXK
Unigon Industries, Inc.
Cardiovascular · 37d
Cleared Sep 09, 1981
PLEURAL DRAINAGE SYSTEM #PDS-4300
K812224 · KDQ
Bentley Laboratories, Inc.
General Hospital · 30d
Cleared Sep 09, 1981
GOLD(AU 195) SPOT MARKER SOURCES
K812235 · IXD
Amersham Corp.
Radiology · 29d
Cleared Sep 09, 1981
GOLD(AU 195) GAMMA CAMERA CHECK(FLOOD)
K812236 · IYO
Amersham Corp.
Radiology · 29d
Cleared Sep 09, 1981
HEMOTOLOGY QUALITY CONTROL MIXTURE
K812237 · JPK
American Dade
Hematology · 29d
Cleared Sep 09, 1981
CT/T 9800
K812241 · JAK
General Electric Co.
Radiology · 29d
Cleared Sep 09, 1981
CORDISNHYPERION HEMOGLOBIN A1 TEST SYS
K812242 · LCP
Cordis Corp.
Hematology · 29d
Cleared Sep 09, 1981
HEMATOLOGY CONTROL
K812280 · JPK
American Dade
Hematology · 27d
Cleared Sep 09, 1981
TRYPTICASE SOY BROTH BLOOD CULTURE BOTT
K812335 · JSC
Fisher Scientific Co., LLC
Microbiology · 22d
Cleared Sep 09, 1981
TERUFUSION INFUSION PUMP MODEL STC-502
K812339 · FRN
Terumo Medical Corp.
General Hospital · 22d
Cleared Sep 09, 1981
IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2
K812355 · CAC
Intl. Business Machines
Hematology · 21d