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
80737–80760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 2000
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
K002143 · FGE
Guidant Corp.
Gastroenterology & Urology · 87d
Cleared Oct 12, 2000
CARRIAZO BARRAQUER II MICROKERATOME
K002191 · HMY
Moria, Inc.
Ophthalmic · 84d
Cleared Oct 12, 2000
SMITH & NEPHEW PORPS & TORPS
K002737 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 41d
Cleared Oct 12, 2000
VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR
K002745 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 37d
Cleared Oct 12, 2000
BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER
K002855 · JGS
Biocare Corp.
Chemistry · 29d
Cleared Oct 12, 2000
INVERNESS MEDICAL OVULATION PREDICTOR TEST
K002867 · CEP
Selfcare, Inc.
Chemistry · 29d
Cleared Oct 12, 2000
SOMATOM EMOTION MS
K003014 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Oct 11, 2000
NARKOMAT, MODEL 2000
K000995 · BSZ
Heyer America, Inc.
Anesthesiology · 197d
Cleared Oct 11, 2000
IRV2000 INDIVIDUAL RECREATIONAL VEHICLE
K001835 · INI
Trac About, Inc.
Physical Medicine · 117d
Cleared Oct 11, 2000
PINS AND WIRES
K002125 · HTY
Implant Resource, Inc.
Orthopedic · 89d
Cleared Oct 11, 2000
MAGNETOM ALLEGRA SYSTEM
K002179 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Oct 11, 2000
UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED...
K002318 · INO
United Chair Mfg., LLC
Physical Medicine · 72d
Cleared Oct 11, 2000
SURGI-VISION URETHRAL COIL
K002345 · MOS
Surgi-Vision, Inc.
Radiology · 70d
Cleared Oct 11, 2000
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL...
K002551 · LEG
Dade Behring, Inc.
Chemistry · 55d
Cleared Oct 11, 2000
EZ-LIGHT 4000 SERIES MANUAL WHEELCHAIR
K002669 · IOR
Jiangsu Intco Medical Equipment &...
Physical Medicine · 44d
Cleared Oct 11, 2000
EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR
K002670 · IOR
Jiangsu Intco Medical Equipment &...
Physical Medicine · 44d
Cleared Oct 11, 2000
EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR
K002671 · IOR
Jiangsu Intco Medical Equipment &...
Physical Medicine · 47d
Cleared Oct 11, 2000
EZ-COMFORT TRANSPORTER 2000 SERIES
K002673 · IOR
Jiangsu Intco Medical Equipment &...
Physical Medicine · 44d
Cleared Oct 11, 2000
COMPOSIX E/X MESH
K002684 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 44d
Cleared Oct 11, 2000
MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500
K002690 · DQA
Nonin Medical, Inc.
Anesthesiology · 43d
Cleared Oct 11, 2000
VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR
K002746 · LYZ
Arista Latindo Industrial Ltd. P.T
General Hospital · 36d
Cleared Oct 11, 2000
JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM
K002876 · IOR
Suiter Medical LLC
Physical Medicine · 27d
Cleared Oct 11, 2000
VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000
K002881 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 26d
Cleared Oct 11, 2000
TITANIUM MIDDLE EAR PROSTHESES
K002897 · ETB
Xomed, Inc.
Ear, Nose, Throat · 23d