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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
78481–78504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 13, 2001
HYDRAGEL ISO-PAL K20 (PN 3022)
K011113 · CIN
Sebia
Chemistry · 63d
Cleared Jun 13, 2001
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL...
K011125 · CAT
Hudson Respiratory Care, Inc.
Anesthesiology · 61d
Cleared Jun 13, 2001
OXYGEN SUPPLY TUBING, MODEL 1115
K011134 · BYX
Hudson Respiratory Care, Inc.
Anesthesiology · 61d
Cleared Jun 13, 2001
ULTRACONCENTRATOR SYSTEM
K011148 · FJI
Interpore Cross Intl.
Gastroenterology & Urology · 58d
Cleared Jun 13, 2001
CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN
K011231 · LYY
Protection Gloves Sdn. Bhd.
General Hospital · 51d
Cleared Jun 13, 2001
BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K011234 · LPL
American Biocurve, Inc.
Ophthalmic · 51d
Cleared Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K011250 · JJX
Ortho-Clinical Diagnostics, Inc.
Microbiology · 50d
Cleared Jun 13, 2001
BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY...
K011316 · LPL
American Contact Lens, Inc.
Ophthalmic · 44d
Cleared Jun 13, 2001
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
K011384 · JTN
Hardy Diagnostics
Microbiology · 37d