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
89785–89808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 03, 1998
SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED)
K980941 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 22d
Cleared Apr 02, 1998
LATEX EXAMINATION GLOVE
K974660 · LYY
Ideal Quality Sdn., Bhd.
General Hospital · 108d
Cleared Apr 02, 1998
POWDER-FREE LATEX EXAMINATION GLOVE
K974662 · LYY
Ideal Quality Sdn., Bhd.
General Hospital · 108d
Cleared Apr 02, 1998
PARA-PAK SPINCON
K980077 · LKS
Meridian Diagnostics, Inc.
Microbiology · 84d
Cleared Apr 02, 1998
COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE
K980168 · LLZ
Analogic Corp.
Radiology · 76d
Cleared Apr 02, 1998
TERUMO DISPOSABLE HYPODERMC SYRINGE
K980181 · FMF
Terumo Medical Corp.
General Hospital · 72d
Cleared Apr 02, 1998
SILIMED NASAL RETAINER
K980221 · LYA
Silimed, LLC
Ear, Nose, Throat · 70d
Cleared Apr 02, 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822
K980224 · MOQ
Alexander Mfg. Co.
General & Plastic Surgery · 70d
Cleared Apr 02, 1998
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP
K980306 · LNH
Elscint, Inc.
Radiology · 65d