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
167401–167424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1980
HAMAS PRECENTERED TOTAL WRIST
K792650 · JWJ
Zimmer, Inc.
Orthopedic · 38d
Cleared Jan 28, 1980
CAMPY BLOOD AGAR
K792674 · JSJ
Regional Media Laboratories
Microbiology · 32d
Cleared Jan 28, 1980
PARA-PAK CLEAN VIAL
K792710 · FMH
Meridian Diagnostics, Inc.
General Hospital · 32d
Cleared Jan 28, 1980
HEXCEL FEMORAL COMPONENT HIP PROSTHESIS
K800051 · JDG
Hexcel Medical
Orthopedic · 19d
Cleared Jan 28, 1980
ANAGO ELECTRO SURGICAL TIP CLEANER
K800058 · GEC
Anago, Inc.
General & Plastic Surgery · 18d
Cleared Jan 28, 1980
DIGITAL ELECTRONIC EXERCISER/PULSE MTR.
K800072 · ISD
Sears, Roebuck & Co.
Physical Medicine · 14d
Cleared Jan 28, 1980
VESSEL OCCLUDER
K800074 · GDJ
Cordis Corp.
General & Plastic Surgery · 14d
Cleared Jan 28, 1980
CRUTCH TIPS, PADS & HAND GRIPS
K800076 · INP
New World Imports, Inc.
Physical Medicine · 14d
Cleared Jan 28, 1980
HEMOCLIP SURGICAL OCCLUDING CLIP
K800079 · FZP
Edward Weck, Inc.
General & Plastic Surgery · 14d
Cleared Jan 28, 1980
STERILIZING CASE CAT. NO. 65199
K800080 · FLE
Edward Weck, Inc.
General Hospital · 14d
Cleared Jan 28, 1980
DAVOL/ABAMSON SILICONE SUMP DRAIN
K800081 · GCY
Davol, Inc.
General & Plastic Surgery · 14d
Cleared Jan 28, 1980
STANFORD STERILE LAP SPONGES
K800102 · GDY
Lukens Corp.
General & Plastic Surgery · 12d
Cleared Jan 28, 1980
SURGICAL STITCH CUTTER
K800103 · FZT
Macon & Co., Inc.
General & Plastic Surgery · 12d
Cleared Jan 24, 1980
NIC-200 VENTRICULAR FUNCTION ANALYZER
K792466 · DQC
Nicolet Biomedical Instruments
Cardiovascular · 52d
Cleared Jan 24, 1980
NEONATAL HEATED HUMIDIFIER
K792620 · BTT
Modern Medical Systems Co.
Anesthesiology · 5d
Cleared Jan 24, 1980
CULTURETTE BRAND-PVA/FORMALIN KIT
K792654 · IFQ
Marion Laboratories, Inc.
Pathology · 29d
Cleared Jan 24, 1980
HELENA COLOSCREEN
K792655 · KHE
Helena Laboratories
Hematology · 29d
Cleared Jan 24, 1980
HELENA FACTOR XII DEFICIENT
K792656 · GGP
Helena Laboratories
Hematology · 29d
Cleared Jan 24, 1980
CAMPY THIO
K792676 · JSJ
Remel Co.
Microbiology · 28d
Cleared Jan 24, 1980
IMMUNODIFFUSION BAND INTENSIFYING FLUID
K792692 · GMK
Meridian Diagnostics, Inc.
Immunology · 28d
Cleared Jan 24, 1980
NEGATIVE CONTROL SERUM
K792694 · GMK
Meridian Diagnostics, Inc.
Microbiology · 28d
Cleared Jan 24, 1980
ANTI-GLOBULIN CONTROL
K792695 · DHR
Meridian Diagnostics, Inc.
Immunology · 28d
Cleared Jan 24, 1980
NORMAL GLOBULIN REAGENT
K792697 · DHR
Meridian Diagnostics, Inc.
Immunology · 28d
Cleared Jan 24, 1980
OUCHTERLONY AGAR PLATES
K792699 · JZQ
Meridian Diagnostics, Inc.
Immunology · 28d