Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
73081–73104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2003
HEMOCHRON RESPONSE/SYSTEM
K030818 · JPA
International Technidyne Corp.
Hematology · 19d
Cleared Apr 02, 2003
EVA EMPTY SOLUTION CONTAINER
K030888 · KPE
Metrix Co.
General Hospital · 12d
Cleared Apr 02, 2003
LEVO COMBI
K030893 · IPL
Levo AG
Physical Medicine · 12d
Cleared Apr 01, 2003
HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103
K021622 · MQM
Hill-Rom Air-Shields
Chemistry · 320d
Cleared Apr 01, 2003
OSTEOMED CRANIAL FLAP FIXATION SYSTEM
K022277 · GXN
Osteomed Corp.
Neurology · 260d
Cleared Apr 01, 2003
CONSTRAINED LINER
K023794 · KWZ
Encore Medical, L.P.
Orthopedic · 139d
Cleared Apr 01, 2003
GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT
K030027 · LPL
Gelflex Laboratories
Ophthalmic · 88d
Cleared Apr 01, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K030094 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 81d
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