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
134809–134832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1988
APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM
K882620 · MSJ
Technicon Instruments Corp.
Immunology · 14d
Cleared Jul 08, 1988
COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM
K882621 · DBI
Technicon Instruments Corp.
Immunology · 14d
Cleared Jul 08, 1988
CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM
K882622 · JFR
Technicon Instruments Corp.
Immunology · 14d
Cleared Jul 08, 1988
PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM
K882623 · JZH
Technicon Instruments Corp.
Immunology · 14d
Cleared Jul 08, 1988
APPOLLO BATH
K882669 · ILK
Electric Mobility Corp.
Physical Medicine · 11d
Cleared Jul 07, 1988
ANTI-CYTOKERATIN MONOCLONAL ANTIBODY
K864893 · LYE
Bd Becton Dickinson Vacutainer...
Pathology · 570d
Cleared Jul 07, 1988
CANNULA MODEL AR-6551
K881792 · HRX
Arthrex Arthroscopy Instruments, Inc.
Orthopedic · 72d
Cleared Jul 07, 1988
ULTRAVIOLET RESOURCES INT'L MODEL 2-FS72
K881923 · FTC
Ultraviolet Resources Intl.
General & Plastic Surgery · 59d
Cleared Jul 07, 1988
PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI
K882381 · KGO
Pioneering Technologies, Inc.
General Hospital · 28d
Cleared Jul 06, 1988
BIOSIGN
K872867 · FRC
Clinical Technology Corp.
General Hospital · 351d
Cleared Jul 06, 1988
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS
K881437 · JJY
Hichem Diagnostics
Chemistry · 92d
Cleared Jul 06, 1988
UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN
K881438 · JJY
Hichem Diagnostics
Chemistry · 92d
Cleared Jul 06, 1988
SHILEY FEMORAL CORONARY PERFUSION CATHETER
K881733 · DWF
Shiley, Inc.
Cardiovascular · 75d
Cleared Jul 06, 1988
LABELING FOR REVISED PASCO MIC AND MIC/ID PANELS
K882029 · JWY
Pasco Laboratories, Inc.
Microbiology · 65d
Cleared Jul 06, 1988
TDX (R) DIGOXIN NXT
K882233 · KXT
Abbott Laboratories
Chemistry · 40d
Cleared Jul 06, 1988
ACCU-CULSHURE TM
K882637 · JTX
Accu-Med Corp.
Microbiology · 9d
Cleared Jul 05, 1988
MODIFIED LABELING FOR TOXI-LAB THC SCREEN
K875182 · DKE
Marion Laboratories, Inc.
Toxicology · 201d
Cleared Jul 05, 1988
PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA
K881691 · DWF
Shiley, Inc.
Cardiovascular · 77d
Cleared Jul 05, 1988
PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)
K881717 · DWS
Buckman Co., Inc.
Cardiovascular · 75d
Cleared Jul 05, 1988
SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER
K881734 · DWF
Shiley, Inc.
Cardiovascular · 74d
Cleared Jul 05, 1988
CONDOM
K881735 · HIS
Iris Medical Ent., Inc.
Obstetrics & Gynecology · 74d
Cleared Jul 05, 1988
ION SELECTIVE ELECTRODE SUBSYSTEM OF PARA. ANALYT.
K882104 · JGS
Paramax Systems Div. Baxter Healthcare
Chemistry · 47d
Cleared Jul 05, 1988
HEARING AID (ALL-IN-THE-EAR)
K882150 · ESD
Clear-Tone Hearing Aid Center
Ear, Nose, Throat · 43d
Cleared Jul 05, 1988
SPTL-1 PULSED DYE LASER
K882243 · GEX
Candela Laser Corp.
General & Plastic Surgery · 35d