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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
128233–128256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1989
NOVA GEL(TM) T JO-1
K896462 · LLL
Inova Diagnostics, Inc.
Immunology · 7d
Cleared Nov 17, 1989
IDEIA HERPES SIMPLEX VIRUS TEST
K871877 · LGC
Boots-Celltech Diagnostics, Inc.
Microbiology · 918d
Cleared Nov 17, 1989
SPORVIEW CULTURE MEDIA
K890754 · FRC
Spsmedical Supply Corp.
General Hospital · 276d
Cleared Nov 17, 1989
TARGET OPIATES-R
K890978 · DJG
V-Tech, Inc.
Toxicology · 263d
Cleared Nov 17, 1989
MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD
K891259 · FNM
Diamond Medical Equipment, Inc.
General Hospital · 254d
Cleared Nov 17, 1989
TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM
K892342 · IZH
Bay Shore Medical Equipment Corp.
Radiology · 226d
Cleared Nov 17, 1989
URETHRAL BALLOON DILATION CATHETER SET
K892855 · KOE
Cook Urological, Inc.
Gastroenterology & Urology · 213d
Cleared Nov 17, 1989
PROTOFLUOR Z
K893038 · JKJ
Helena Laboratories
Chemistry · 207d
Cleared Nov 17, 1989
OLYMPUS PK(TM) TP
K893124 · GMT
Fujirebio Diagnostics,Inc.
Microbiology · 206d
Cleared Nov 17, 1989
LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX)
K893351 · LYY
China National Medicines & Health...
General Hospital · 210d
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