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

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175,820 results
128833–128856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 1989
HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL
K894402 · LLZ
Hipgraphics, Inc.
Radiology · 123d
Cleared Nov 17, 1989
BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
K894604 · KXA
Biopro, Inc.
Orthopedic · 120d
Cleared Nov 17, 1989
POROUS-COATED TITANIUM ACETABULAR CUP
K894965 · JDL
Dow Corning Wright
Orthopedic · 102d
Cleared Nov 17, 1989
EAGLE DS
K895164 · ECG
American Sterilizer Co.
Dental · 87d
Cleared Nov 17, 1989
PAPPAS TRI-FLANGE VENTILATION TUBE
K895242 · ETD
Richards Medical Co., Inc.
Ear, Nose, Throat · 88d
Cleared Nov 17, 1989
FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE
K895245 · EOB
Optimed Technologies, Inc.
Ear, Nose, Throat · 88d
Cleared Nov 17, 1989
ORTHOPHOS AND ORTHOPHOS C
K895467 · EHD
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Nov 17, 1989
PATIENT EXAMINATION GLOVES
K895557 · LYY
Moeller Chemicals, Inc.
General Hospital · 86d
Cleared Nov 17, 1989
POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT
K895607 · JDL
Exactech, Inc.
Orthopedic · 60d
Cleared Nov 17, 1989
LATEX PATIENT EXAMINATION GLOVES
K895716 · LYY
Lizhu Sanitary Materials Factory
General Hospital · 53d
Cleared Nov 17, 1989
GE MR MAX SYSTEM
K895794 · LNH
GE Medical Systems
Radiology · 50d
Cleared Nov 17, 1989
LIFEPORT POLYURETHANE CATHETER
K895871 · LJT
Strato Medical Corp.
General Hospital · 44d
Cleared Nov 17, 1989
THE COMFORTABLE CANNULA
K896036 · CAT
Comfortable Concepts Corp.
Anesthesiology · 31d
Cleared Nov 17, 1989
VISION PHENYTOIN
K896074 · DIP
Abbott Laboratories
Chemistry · 29d
Cleared Nov 17, 1989
FEMORAL ANGIOGRAPHY DRAPE
K896088 · IZI
Medical Plastics, Inc.
Radiology · 29d
Cleared Nov 17, 1989
ENTRAPPING FILTER
K896116 · CAH
Cadema Medical Products, Inc.
General Hospital · 28d
Cleared Nov 17, 1989
FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT
K896222 · CEC
Nichols Institute Diagnostics
Chemistry · 18d
Cleared Nov 16, 1989
LIGHT COAGULATOR LC 250
K881334 · HAM
Nk-Optik GmbH
General & Plastic Surgery · 596d
Cleared Nov 16, 1989
MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM
K892359 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 224d
Cleared Nov 16, 1989
RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS
K893377 · HSB
Richards Medical Co., Inc.
Orthopedic · 199d
Cleared Nov 16, 1989
QCR SYSTEM I AND QCR SYSTEM II
K893380 · LGH
Bremer Mfg. & Tool Co., Inc.
Orthopedic · 199d
Cleared Nov 16, 1989
CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS
K893499 · EQJ
Cmsi
Ear, Nose, Throat · 196d
Cleared Nov 16, 1989
LATEX EXAMINATION GLOVES (POWDER-FREE/HYPO-ALLER.)
K894497 · LYY
Safeskin Corp.
General Hospital · 125d
Cleared Nov 16, 1989
LATEX PATIENT EXAMINATION GLOVE
K895023 · LYY
Beijing Latex Factory
General Hospital · 119d