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
163753–163776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1981
OXIMETRIX ACCU SAT CPB
K811391 · DRY
Oximetrix, Inc.
Cardiovascular · 63d
Cleared Jul 20, 1981
DEPUY HEMODRAIN
K811557 · GCY
Depuy, Inc.
General & Plastic Surgery · 48d
Cleared Jul 20, 1981
THERMOMETER (MADE IN CHINA)
K811631 · FLK
Robert I. Chien & Assoc., Inc.
General Hospital · 41d
Cleared Jul 20, 1981
SURGICAL INSTRUMENTS
K811686 · GEN
C.V.I., Inc.
General & Plastic Surgery · 35d
Cleared Jul 20, 1981
CORDIS OMNI-ARTICOR CARDIAC PACER #308
K811691 · DXY
Cordis Corp.
Cardiovascular · 35d
Cleared Jul 20, 1981
AXICUT DISPOSABLE SCALPEL
K811707 · GDX
Neonatal Corp.
General & Plastic Surgery · 34d
Cleared Jul 20, 1981
TIP WIPE
K811712 · KDC
Devon Industries, Inc.
General & Plastic Surgery · 33d
Cleared Jul 20, 1981
ROTA CAMERA
K811715 · IYX
Siemens Gammasonics, Inc.
Radiology · 32d
Cleared Jul 20, 1981
GATOR DRAPES
K811717 · KQM
The Anspach Effort, Inc.
General & Plastic Surgery · 32d
Cleared Jul 20, 1981
WHOLE BODY SCANNER
K811723 · JAK
Cgr Medical Corp.
Radiology · 32d
Cleared Jul 20, 1981
CASTLE & RITTER MINOR SURG. & EXAM LT
K811728 · FTD
Sybron Corp.
General & Plastic Surgery · 32d
Cleared Jul 20, 1981
COLLARLESS TAPERED STEM HIP PROSTH. DEV
K811738 · KWL
Biomet, Inc.
Orthopedic · 31d
Cleared Jul 20, 1981
MULTITUBULAR THORACIC AIR SPLINTS
K811750 · IPT
Roger Cestac & Assoc.
Physical Medicine · 28d
Cleared Jul 20, 1981
CRYSTONA
K811754 · ITG
Smith & Nephew, Inc.
Physical Medicine · 28d
Cleared Jul 20, 1981
RETRACTING PROBES
K811759 · GAD
American V. Mueller
General & Plastic Surgery · 28d
Cleared Jul 20, 1981
CORATOMIC MODEL OVALITH-920BP
K811768 · DXY
Corptomic
Cardiovascular · 28d
Cleared Jul 20, 1981
TIP-VU
K811822 · KDC
Instranetics, Inc.
General & Plastic Surgery · 21d
Cleared Jul 20, 1981
SHARPS CADDY FB
K811823 · KDC
Instranetics, Inc.
General & Plastic Surgery · 21d
Cleared Jul 20, 1981
CAUTERY CADDY PAD
K811824 · KDC
Instranetics, Inc.
General & Plastic Surgery · 21d
Cleared Jul 20, 1981
MICRO OSCILLATING SAW
K811834 · HSZ
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 20d
Cleared Jul 20, 1981
IVAC 700 SYRINGE INFUSION PUMP
K811884 · FRN
Y
General Hospital · 19d
Cleared Jul 20, 1981
NORELCO MASSAGER PLUS HEAT BELT
K811891 · ISA
North American Philips Corp.
Physical Medicine · 19d
Cleared Jul 20, 1981
CENTURY HYDROTHERAPY PUMP
K811903 · ILJ
Century Manufacturing Co.
Physical Medicine · 19d
Cleared Jul 20, 1981
CENTURY HYDRO-SAN THERAPY TANK
K811904 · ILJ
Century Manufacturing Co.
Physical Medicine · 19d