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
83881–83904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 1999
ALARMVIEW SYSTEM
K992848 · MSX
Data Critical Corp.
Cardiovascular · 87d
Cleared Nov 19, 1999
HI BOND NON-PRECIOUS CERAMIC ALLOY
K992881 · EJH
Matech, Inc.
Dental · 85d
Cleared Nov 19, 1999
VERSALOK LOW BACK FIXATION SYSTEM
K992885 · KWP
Osteotech, Inc.
Orthopedic · 84d
Cleared Nov 19, 1999
OXY-GLIDE ROOT CANAL CLEANSER & LUB.
K992919 · KJJ
Super Glide, Inc.
Dental · 81d
Cleared Nov 19, 1999
LORENZ DISTRACTION SYSTEM
K992952 · MQN
Walter Lorenz Surgical, Inc.
Dental · 79d
Cleared Nov 19, 1999
IBC VENT VALVE, MODEL 1400
K992964 · MNJ
International Biophysics Corp.
Cardiovascular · 78d
Cleared Nov 19, 1999
DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES
K993049 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 70d
Cleared Nov 19, 1999
STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM
K993061 · MAI
Stryker Instruments
Orthopedic · 67d
Cleared Nov 19, 1999
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR...
K993082 · LPH
Exactech, Inc.
Orthopedic · 65d
Cleared Nov 19, 1999
POWDER FREE GLOVES (POLYMER COATED)
K993183 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 57d
Cleared Nov 19, 1999
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE
K993311 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 46d
Cleared Nov 19, 1999
NIL, NITRILE EXAMINATION GLOVE - POWDERED
K993347 · LZA
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 45d
Cleared Nov 19, 1999
NIL, NITRILE EXAMINATION GLOVE - POWDER FREE
K993348 · LZA
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 45d
Cleared Nov 19, 1999
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
K993352 · LPH
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Nov 19, 1999
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE
K993419 · LYY
Omnigrace , Ltd.
General Hospital · 38d
Cleared Nov 19, 1999
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100...
K993479 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 36d
Cleared Nov 19, 1999
MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES
K993555 · DQA
Masimo Corp.
Anesthesiology · 30d
Cleared Nov 19, 1999
WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW
K993603 · HSB
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Nov 19, 1999
EBI XFIX DFS WRISTFIX SYSTEM
K993649 · KTT
Ebi, L.P.
Orthopedic · 21d
Cleared Nov 19, 1999
MED-4000
K993823 · GZJ
Micro Current Technology, Inc.
Neurology · 7d
Cleared Nov 18, 1999
WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS
K983239 · FIP
Rasco
Gastroenterology & Urology · 429d
Cleared Nov 18, 1999
STAR TEMPORARY WOUND COVER
K983753 · FTL
Osteogenics, Inc.
General & Plastic Surgery · 398d
Cleared Nov 18, 1999
COLORMAX COLOR VISION ENHANCEMENT LENSES
K984219 · NAI
Color Vision Technologies, Inc.
Ophthalmic · 358d
Cleared Nov 18, 1999
NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR
K990177 · CBK
Nellcor Puritan Bennett, Inc.
Anesthesiology · 303d