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

Filters: Cleared only ×
175,820 results
101401–101424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 1995
DERRICK SURESHIELD
K953712 · KGO
M.P.S. Pharm'L Int'L
General Hospital · 64d
Cleared Oct 12, 1995
FOR MED HIGH RISK
K953740 · LYY
For Med, Inc.
General Hospital · 63d
Cleared Oct 12, 1995
STERIKING STERILIZATION POUCHES & ROLLS
K953776 · KCT
Wihuri OY
General Hospital · 62d
Cleared Oct 12, 1995
DALL-MILES SUTURE/BEADED CABLE
K953818 · JDQ
Howmedica Corp.
Orthopedic · 58d
Cleared Oct 12, 1995
ACE CERVICAL TRACTION HALOZS, TONGS & PINS
K954069 · HAX
Ace Medical Co.
Orthopedic · 43d
Cleared Oct 12, 1995
AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM...
K954244 · DYH
American Dental Products, Inc.
Dental · 31d
Cleared Oct 12, 1995
AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM
K954333 · DYH
American Dental Products, Inc.
Dental · 24d
Cleared Oct 12, 1995
ARGISTAR 74
K954362 · EJT
Argen Precious Metals, Inc.
Dental · 24d
Cleared Oct 11, 1995
LAPOROSCOPIC SCISSORS
K942431 · HET
Enterprise Medical Corp.
Obstetrics & Gynecology · 509d
Cleared Oct 11, 1995
J.B.S. ANTERIOR SPINE SYSTEM(R)
K950209 · KWQ
J.B.S. (Usa), Inc.
Orthopedic · 265d
Cleared Oct 11, 1995
GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB
K952275 · BSP
Global Medical Prods, Inc.
Anesthesiology · 149d
Cleared Oct 11, 1995
CASRRASYN ORAL WOUND DRESSING
K953423 · OLR
Carrington Laboratories, Inc.
General & Plastic Surgery · 113d
Cleared Oct 11, 1995
TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL
K954322 · DIF
Medical Analysis Systems, Inc.
Toxicology · 26d
Cleared Oct 07, 1995
COMPUTER DYNO/GONIO/MYO GRAPHY
K942965 · IKN
Infotronic Medical Engineering
Neurology · 470d
Cleared Oct 07, 1995
DISETRONIC D-MODEM
K943952 · FRN
Disetronic Medical Systems
General Hospital · 418d
Cleared Oct 07, 1995
MAGNETOM VISION (PROJECT 016)
K945517 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 332d
Cleared Oct 07, 1995
CHLAMYDIA OIA
K951010 · LJC
Biostar, Inc.
Microbiology · 215d
Cleared Oct 07, 1995
JUSTONE
K951240 · JWY
Radiometer America, Inc.
Microbiology · 222d
Cleared Oct 07, 1995
HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
K951241 · JWY
Radiometer America, Inc.
Microbiology · 222d
Cleared Oct 07, 1995
SAFETYGLIDE NEEDLE
K951254 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 200d
Cleared Oct 07, 1995
GORE-TEX MYCROMESH BIOMATERIAL
K951675 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 179d
Cleared Oct 07, 1995
GORE-TEX DUALMESH BIOMATERIAL
K951676 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 179d
Cleared Oct 07, 1995
GORE-TEX SOFT TISSUE PATCH
K951700 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 178d
Cleared Oct 07, 1995
UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT...
K951764 · IYE
Ptw-New York Corp.
Radiology · 173d