FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
130993–131016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1989
AEROMAT MRS-1000
K893614 · IOQ
Integrated Therapy Products, Inc.
Physical Medicine · 43d
Cleared Jun 22, 1989
COLD/HOT FLUID RADIATION PAD NEUTECH
K893706 · ILO
Burke, Inc.
Physical Medicine · 35d
Cleared Jun 22, 1989
FLUIDIZED AIR BED
K893708 · IOQ
Gsi Development Co.
Physical Medicine · 35d
Cleared Jun 22, 1989
TISSUE EMBEDDING MEDIUM
K893772 · KEO
Stephens Scientific
Pathology · 31d
Cleared Jun 21, 1989
MP TEST
K882596 · LJZ
Diatech Diagnostica , Ltd.
Microbiology · 362d
Cleared Jun 21, 1989
PHARMA-PLAST INSULIN INFUSION SET
K884978 · LZG
Pharma-Plast USA, Inc.
General Hospital · 203d
Cleared Jun 21, 1989
SANITARY NAPKIN PADS
K890125 · HHD
Landen Corp.
Obstetrics & Gynecology · 162d
Cleared Jun 21, 1989
HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.
K890864 · ETY
Rastronics USA, Inc.
Ear, Nose, Throat · 120d
Cleared Jun 21, 1989
PATIENT EXAMINATION GLOVES
K890930 · LYY
Thaima Products Co., Ltd.
General Hospital · 117d
Cleared Jun 21, 1989
ACS COLLOID OSMOTIC PRESSURE CALIBRATOR
K892213 · JIW
Analytical Control Systems, Inc.
Chemistry · 79d
Cleared Jun 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892309 · LYY
Min an Chemical Industrial Co., Ltd.
General Hospital · 76d
Cleared Jun 21, 1989
PATIENT EXAMINATION GLOVES
K892480 · LYY
Foodhandler, Inc.
General Hospital · 75d
Cleared Jun 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892506 · LYY
Universal Latex Products Co., Ltd.
General Hospital · 69d
Cleared Jun 21, 1989
CANNULATED BIOPSY FORCEPS
K892687 · EOQ
Zinnanti Surgical Instruments, Inc.
Ear, Nose, Throat · 69d
Cleared Jun 21, 1989
PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION
K892915 · KDQ
Deknatel, Inc.
General Hospital · 62d
Cleared Jun 21, 1989
DELTA (TM) ROBOTIC PIPETTOR
K893031 · JQW
Diagnostic Products Corp.
Chemistry · 58d
Cleared Jun 21, 1989
SHARPLAN 1075 CO2 LASER
K893206 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 56d
Cleared Jun 21, 1989
SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE
K893255 · DYH
American Orthodontics
Dental · 54d
Cleared Jun 21, 1989
LATEX SURGICAL GLOVES
K893340 · KGO
Kenmark Industrial Co., Ltd.
General Hospital · 57d
Cleared Jun 21, 1989
SLT CONTACT LASER SYSTEM
K893701 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 34d
Cleared Jun 21, 1989
BACTON TM, BASIC TM, APO B REAGENT
K893884 · MSJ
Catachem, Inc.
Immunology · 22d
Cleared Jun 21, 1989
BACTON TM, BASIC TM, APO A-I REAGENT
K893885 · DEL
Catachem, Inc.
Chemistry · 22d
Cleared Jun 20, 1989
PACEMAKER LEAD ADAPTER
K890018 · DTB
Ela Medical, Inc.
Cardiovascular · 168d
Cleared Jun 20, 1989
VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM
K890047 · LYK
Vascucare, Inc.
Cardiovascular · 166d