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
90289–90312 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1998
OZ POWER SYRINGE
K973334 · DXT
Cardiovascular Innovations
Cardiovascular · 211d
Cleared Apr 03, 1998
PROFUSION BONE VOID FILLER
K973704 · MQV
Biogeneration
Orthopedic · 186d
Cleared Apr 03, 1998
REJUVENESS
K974380 · MDA
Rejuveness Pharamceuticals, Inc.
General & Plastic Surgery · 164d
Cleared Apr 03, 1998
ACTIVELOCK MODULAR FEMORAL HIP SYSTEM
K980020 · LPH
Metagen, LLC
Orthopedic · 88d
Cleared Apr 03, 1998
XENON 300MX
K980044 · FSS
Perkinelmer Optoelectronics
General & Plastic Surgery · 87d
Cleared Apr 03, 1998
BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
K980102 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 81d
Cleared Apr 03, 1998
WALLSTENT ENTERAL ENDOPROSTHESIS
K980113 · MUM
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 80d
Cleared Apr 03, 1998
SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
K980138 · FWP
Spectrum Designs, Inc.
General & Plastic Surgery · 78d
Cleared Apr 03, 1998
FEATHERLITE DIODE LASER
K980142 · GEX
Laserlite, LLC
General & Plastic Surgery · 78d
Cleared Apr 03, 1998
MLT R694 RUBY LASER SYSTEM
K980187 · GEX
Medical Laser Technologies , Ltd.
General & Plastic Surgery · 73d
Cleared Apr 03, 1998
PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)
K980243 · LMB
Parameter Developments, Inc.
Radiology · 70d
Cleared Apr 03, 1998
ULTIMA ACETABULAR ROOF REINFORCEMENT RING
K980286 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 67d
Cleared Apr 03, 1998
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW
K980440 · HWC
Depuy, Inc.
Orthopedic · 58d
Cleared Apr 03, 1998
MODEL PS-1 PENA MUSCLE STIMULATOR
K980448 · IPF
Radionics, Inc.
Physical Medicine · 57d
Cleared Apr 03, 1998
KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE
K980469 · MQX
American Institute of Koryo Hand Therapy
General Hospital · 56d
Cleared Apr 03, 1998
PLAYTEX TAMPONS #03498
K980478 · HEB
Playtex, Inc.
Obstetrics & Gynecology · 56d
Cleared Apr 03, 1998
DERMATHERM 100
K980607 · ILY
New Star Lasers, Inc.
Physical Medicine · 45d
Cleared Apr 03, 1998
ENDOBON
K980679 · LYC
Biomet, Inc.
Dental · 42d
Cleared Apr 03, 1998
FUJI II
K980682 · EMA
GC America, Inc.
Dental · 39d
Cleared Apr 03, 1998
ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY
K980716 · LTJ
Nichols Institute Diagnostics
Immunology · 86d
Cleared Apr 03, 1998
STERILE POWDER-FREE LATEX EXAMINATION GLOVES
K980803 · LYY
Kenwell International , Ltd.
General Hospital · 32d
Cleared Apr 03, 1998
BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS
K980819 · CEC
Biocircuits Corp.
Chemistry · 31d
Cleared Apr 03, 1998
SAFETY POWDERED BLUE LATEX EXAMINATION GLOVES
K980939 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 22d
Cleared Apr 03, 1998
SAFETY POWDERFREE BLUE LATEX EXAMINTION GLOVES
K980940 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 22d