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
91201–91224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 1997
TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP
K970326 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 297d
Cleared Nov 21, 1997
GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
K971781 · HRX
Wilson Greatbatch Technologies, Inc.
Orthopedic · 191d
Cleared Nov 21, 1997
FLEXTIP GRASPER
K972450 · EOB
Endius, Inc.
Ear, Nose, Throat · 144d
Cleared Nov 21, 1997
URESIL GUIDEWIRE
K972582 · FGE
Uresil Corp.
Gastroenterology & Urology · 134d
Cleared Nov 21, 1997
ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
K973163 · LPH
Howmedica Corp.
Orthopedic · 88d
Cleared Nov 21, 1997
DOW CORNING SILASTIC ELASTOMER Q7-4750
K973166 · MIB
Technical Products, Inc.
General & Plastic Surgery · 88d
Cleared Nov 21, 1997
SMARTVIEW OPTIONS FOR HISPEED CT/I
K973168 · JAK
GE Medical Systems
Radiology · 88d
Cleared Nov 21, 1997
SEIZURE EMERGENCY EQUIPMENT KIT
K973176 · KGA
Lotus Technologies
Anesthesiology · 88d
Cleared Nov 21, 1997
PROSTATE SEEDING NEEDLE
K973184 · IWJ
Promex, Inc.
Radiology · 88d
Cleared Nov 21, 1997
ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES
K973190 · GEI
Cryomedical Sciences, Inc.
General & Plastic Surgery · 88d
Cleared Nov 21, 1997
LUXSCOPE
K973193 · HQF
Luxtec Corp.
Ophthalmic · 88d
Cleared Nov 21, 1997
OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS...
K973232 · GCJ
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 85d
Cleared Nov 21, 1997
SPIROSAFE FILTER
K973314 · CAH
Micro Direct, Inc.
General Hospital · 79d
Cleared Nov 21, 1997
ELECSYS AFP
K973351 · LOJ
Boehringer Mannheim Corp.
Immunology · 77d
Cleared Nov 21, 1997
K-PISTON WITH BAND HOOK /ANGULAR PISTON
K973356 · ETB
Heinz Kurz
Ear, Nose, Throat · 74d
Cleared Nov 21, 1997
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
K973369 · LBR
Roche Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Nov 21, 1997
SYNTAC SPRINT
K973397 · EMA
Ivoclar North America, Inc.
Dental · 73d
Cleared Nov 21, 1997
ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100
K973642 · EHD
Instrumentarium Imaging, Inc.
Radiology · 58d
Cleared Nov 21, 1997
REFLECTIONS
K973776 · DYW
Cdb Corp.
Dental · 49d
Cleared Nov 21, 1997
HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)
K973801 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 46d
Cleared Nov 21, 1997
HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR)
K973815 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 45d
Cleared Nov 21, 1997
GIOTTO HT
K973856 · IZH
Sitco, Inc.
Radiology · 43d
Cleared Nov 21, 1997
VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE
K973889 · IYE
Varian Medical Systems, Inc.
Radiology · 38d
Cleared Nov 21, 1997
STEALTHSTATION SYSTEM
K974161 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 86d