FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
72481–72504 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 2003
ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
K030153 · JDI
Zimmer, Inc.
Orthopedic · 75d
Cleared Apr 01, 2003
HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM
K030198 · HRS
Hand Innovations, Inc.
Orthopedic · 70d
Cleared Apr 01, 2003
CONSENSUS UNIPOLAR HEAD, COCR
K030205 · KWL
Hayes Medical, Inc.
Orthopedic · 70d
Cleared Apr 01, 2003
SELITHERM, MODEL C100
K030382 · IMJ
Selicor, Inc.
Physical Medicine · 55d
Cleared Apr 01, 2003
SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE
K030390 · LXT
Synthes (Usa)
Orthopedic · 55d
Cleared Apr 01, 2003
HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE
K030572 · EOB
Henke Sass Wolf of America, Inc.
Ear, Nose, Throat · 36d
Cleared Apr 01, 2003
ODI 7.0MM CANNULATED SCREW SYSTEM
K030619 · HTN
Orthopedic Designs, Inc.
Orthopedic · 33d
Cleared Apr 01, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE
K030677 · LON
Becton, Dickinson & CO
Microbiology · 28d
Cleared Apr 01, 2003
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
K030740 · GHH
Roche Diagnostics Corp.
Hematology · 22d
Cleared Apr 01, 2003
SUPEROPEN 0.35T, MODEL NSM-P035
K030918 · LNH
Neusoft Digital Medical Systems Co.,...
Radiology · 8d
Cleared Apr 01, 2003
RITA CLIPS FOR INFUSION PUMPS
K030936 · MRZ
Rita Medical Systems, Inc.
General Hospital · 7d
Cleared Mar 31, 2003
VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
K023381 · DTZ
Gish Biomedical, Inc.
Cardiovascular · 174d
Cleared Mar 31, 2003
VBL SERUM TROPONIN I TEST, MODEL 1001
K023505 · MMI
Vancouver Biotech , Ltd.
Chemistry · 164d
Cleared Mar 31, 2003
GISH ARTERIAL FILTER WITH GBS COATING
K023833 · DTM
Gish Biomedical, Inc.
Cardiovascular · 133d
Cleared Mar 31, 2003
G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
K024006 · JBF
Pointe Scientific, Inc.,
Chemistry · 117d
Cleared Mar 31, 2003
CANDELA GENTLE LASE FAMILY OF LASER SYSTEM
K024371 · GEX
Candela Corp.
General & Plastic Surgery · 90d
Cleared Mar 31, 2003
ITI DENTAL IMPLANT SYSTEM
K030007 · DZE
Straumann USA
Dental · 89d
Cleared Mar 31, 2003
JOSTENT SELFX, MODELS 015SX4406
K030053 · FGE
Jomed AG
Gastroenterology & Urology · 98d
Cleared Mar 31, 2003
IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP,...
K030154 · KFM
Dideco S.P.A.
Cardiovascular · 74d
Cleared Mar 31, 2003
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
K030616 · LAS
Microgenics Corp.
Toxicology · 33d
Cleared Mar 31, 2003
SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL...
K030653 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 28d
Cleared Mar 31, 2003
QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
K030721 · LRO
Ballard Medical Products
General & Plastic Surgery · 24d
Cleared Mar 28, 2003
REPROCESSED PULSE OXIMETER SENSORS
K012677 · NLF
Sterilmed, Inc.
Anesthesiology · 591d
Cleared Mar 28, 2003
MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C
K022446 · EOQ
Aomori Olympus Co., Ltd.
Ear, Nose, Throat · 246d