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
128377–128400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1989
AVL MODEL 912 CO-OXYLITE
K895466 · GLY
Avl Scientific Corp.
Hematology · 56d
Cleared Nov 06, 1989
PATIENT POSITIONING ACCESSORIES
K895500 · IYE
Perkins Mfg. Co.
Radiology · 55d
Cleared Nov 06, 1989
PEMACO 3000 INTRAORAL DENTAL WAX
K895561 · EGD
Pemaco, Inc.
Dental · 61d
Cleared Nov 06, 1989
PEMACO 2000 INTRAORAL DENTAL WAX
K895562 · EGD
Pemaco, Inc.
Dental · 61d
Cleared Nov 06, 1989
PEMACO BITE WAX SHEETS
K895563 · EGD
Pemaco, Inc.
Dental · 61d
Cleared Nov 06, 1989
PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD
K895564 · EGD
Pemaco, Inc.
Dental · 61d
Cleared Nov 06, 1989
PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT
K895566 · EGD
Pemaco, Inc.
Dental · 61d
Cleared Nov 06, 1989
STIMTRAC II CATALOG NUMBER 78-8500
K895671 · IPF
Stimtech Products
Physical Medicine · 47d
Cleared Nov 06, 1989
BIOPSY NEEDLE GUIDE FOR ADMS ULTRASOUND PROBES
K895725 · FCG
Interson Corp.
Gastroenterology & Urology · 42d
Cleared Nov 06, 1989
X-RAY EQUIPMENT (VARIOUS TYPES)
K895730 · JAA
Continental X-Ray Corp.
Radiology · 45d
Cleared Nov 06, 1989
RHEUMELISA ASSAY FOR SM AUTOANTIBODIES
K895996 · LKP
Lipogen, Inc.
Immunology · 24d
Cleared Nov 06, 1989
RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES
K895997 · LKO
Lipogen, Inc.
Immunology · 24d
Cleared Nov 06, 1989
MODIFIED QM300 ALBUMIN ANTIBODY PACK
K896059 · DCF
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Nov 03, 1989
MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIES
K890665 · HRX
Dyonics, Inc.
Orthopedic · 267d
Cleared Nov 03, 1989
BIOFIX* BIODEGRADABLE FIXATION ROD
K890902 · HTY
Davis & Geck, Inc.
Orthopedic · 254d
Cleared Nov 03, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891256 · LYY
Raewiks, Inc.
General Hospital · 240d
Cleared Nov 03, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892167 · LYY
Raewiks, Inc.
General Hospital · 212d
Cleared Nov 03, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892561 · LYY
Maxicare Mfg. Corp.
General Hospital · 207d
Cleared Nov 03, 1989
TERM GUARD II DEVICE
K893770 · HFM
Tokos Medical Corp.
Obstetrics & Gynecology · 165d
Cleared Nov 03, 1989
LEVTECH SMALL BONE PLATE
K893928 · KTW
Buckman Co., Inc.
Orthopedic · 156d
Cleared Nov 03, 1989
SANISERV SURGICAL SLUSH SYSTEM
K894006 · JRM
Saniserv, Inc.
Physical Medicine · 151d
Cleared Nov 03, 1989
FULL ITE, LOW PROFILE, HELIX, CANAL COMBIN/SD CANA
K894176 · ESD
Precision Hearing Instruments
Ear, Nose, Throat · 141d
Cleared Nov 03, 1989
PATIENT EXAMINATION GLOVES
K894352 · LYY
Rego Latex Progressive Corp.
General Hospital · 112d
Cleared Nov 03, 1989
MODEL 410 ALERT AND TELECOMMUNICATION SYSTEM
K894958 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 88d