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
162913–162936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 20, 1981
VEIN-TRAP TM
K811910 · DWQ
Atrium Medical Corp.
Cardiovascular · 19d
Cleared Jul 20, 1981
AMP MARK IV INFUSION PUMP
K811918 · FRN
American Medical Products, Inc.
General Hospital · 18d
Cleared Jul 20, 1981
GUARDIAN, VOLUMETRIC CONTROL DELIVERY
K811933 · FRN
Avi, Inc.
General Hospital · 14d
Cleared Jul 20, 1981
VISITEC NEEDLE RANGE (ORTHOPAEDIC)
K811961
Visitec Co.
Orthopedic · 10d
Cleared Jul 20, 1981
VISITEC NEEDLE RANGE (CARDIOVASCULAR)
K811964 · DRC
Visitec Co.
Cardiovascular · 10d
Cleared Jul 20, 1981
JOHNSON & JOHNSON O.B. TAMPONS
K811983 · HEB
Johnson & Johnson Professionals, Inc.
Obstetrics & Gynecology · 7d