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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
71953–71976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2003
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
K024350 · LYR
ACON Laboratories, Inc.
Microbiology · 93d
Cleared Apr 02, 2003
KSEA POWERSHAVER SYSTEM S2
K030009 · HRX
Karl Storz Endoscopy
Orthopedic · 90d
Cleared Apr 02, 2003
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH...
K030167 · LPL
Clearlab Pte , Ltd.
Ophthalmic · 76d
Cleared Apr 02, 2003
COLONCARE
K030216 · KHE
Care Products, Inc.
Hematology · 71d
Cleared Apr 02, 2003
MRI-CADDY
K030323 · FRN
Mammendorfer Institute For Physics &...
General Hospital · 62d
Cleared Apr 02, 2003
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT
K030686 · JWH
Exactech, Inc.
Orthopedic · 28d
Cleared Apr 02, 2003
VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
K030736 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d
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