FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78985–79008 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 2001
EXETER HIP SYSTEM WITH V40 TAPER
K011623 · JDI
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jun 14, 2001
COMOACT ULTRASONIC NEBULIZER, MODEL 3060
K002543 · CAF
San UP S.A.
Anesthesiology · 302d
Cleared Jun 14, 2001
PULSECO HEMODYNAMIC MONITOR CM71
K010049 · DXG
Lidco, Ltd.
Cardiovascular · 160d
Cleared Jun 14, 2001
COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
K010055 · DRE
Cook Vascular, Inc.
Cardiovascular · 157d
Cleared Jun 14, 2001
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
K010093 · CBK
Drager Medizintechnik GmbH
Anesthesiology · 154d
Cleared Jun 14, 2001
PORTABLE INSTENSIVE CARE UNIT
K010207 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 142d
Cleared Jun 14, 2001
DIMENSION DRUG CALIBRATOR, MODEL DC22B
K011035 · JIX
Dade Behring, Inc.
Chemistry · 70d
Cleared Jun 14, 2001
BCI 3403 SLEEP SCREENING PULSE OXIMETER
K011156 · DQA
Bci, Inc.
Anesthesiology · 59d
Cleared Jun 14, 2001
GILB, MODEL 8010
K011200 · EMA
3M Company
Dental · 56d
Cleared Jun 14, 2001
SLT LASERPRO CTH HOLMIUM LASER SYSTEM
K011409 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 37d
Cleared Jun 14, 2001
BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
K011446 · KGO
Barriermed, Inc.
General Hospital · 34d
Cleared Jun 14, 2001
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138
K011523 · DXN
Rossmax International , Ltd.
Cardiovascular · 28d
Cleared Jun 14, 2001
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129,...
K011526 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 28d
Cleared Jun 13, 2001
MEMODYN STAPLE
K002695 · JDR
Telos Medical Equipment
Orthopedic · 288d
Cleared Jun 13, 2001
YOUNG-HEALTH SUPER EAR THERMOMETER
K002727 · FLL
Young Health Ind. Co., Ltd.
General Hospital · 286d
Cleared Jun 13, 2001
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
K003259 · LGD
Beckman Coulter, Inc.
Microbiology · 238d
Cleared Jun 13, 2001
PROACT 1
K003909 · IRP
Proact Co.
Physical Medicine · 176d
Cleared Jun 13, 2001
AVIATOR PERIPHERAL DILATATION CATHETER
K010831 · DQY
Guidant Corp.
Cardiovascular · 85d
Cleared Jun 13, 2001
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)
K010854 · LYY
Protection Gloves Sdn. Bhd.
General Hospital · 83d
Cleared Jun 13, 2001
PLLA PIN
K010983 · HTY
Bionx Implants, Inc.
Orthopedic · 72d
Cleared Jun 13, 2001
LUNAPADS
K010986 · NUQ
Lunapads International Products, Ltd.
Obstetrics & Gynecology · 72d
Cleared Jun 13, 2001
FORTADERM WOUND DRESSING
K011026 · KGN
Organogenesis, Inc.
General & Plastic Surgery · 70d
Cleared Jun 13, 2001
MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM
K011095 · IYO
Iodp SA
Radiology · 64d
Cleared Jun 13, 2001
BD SPRING BASED SYRINGE
K011103 · MEG
Bd
General Hospital · 63d