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
115513–115536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 1992
I-STAT(TM) LEVELS 1,2,3 CONTROLS
K921477 · JJY
I-Stat Corp.
Chemistry · 217d
Cleared Nov 02, 1992
IBT MODEL SVI
K921821 · CBK
Biomagnetic Technologies, Inc.
Anesthesiology · 200d
Cleared Nov 02, 1992
TAD MODEL #9655
K921898 · DRS
Loric Technology
Cardiovascular · 194d
Cleared Nov 02, 1992
HARRIS MODEL 2000
K921906 · LMC
Harris Mfg. Co.
Radiology · 195d
Cleared Nov 02, 1992
321Q MINIMUM ENERGY TINNITUS SUPPRESSOR
K922572 · KLW
Microbio-Medics, Inc.
Ear, Nose, Throat · 154d
Cleared Nov 02, 1992
KING DIAGNOSTICS GLUCOSE (HK) REAGENT
K923129 · CFR
King Diagnostics, Inc.
Chemistry · 129d
Cleared Nov 02, 1992
NIZYME TEST KIT
K923566 · JSX
Remel Co.
Microbiology · 108d
Cleared Nov 02, 1992
REP IMMUNOFIX
K923658 · CFF
Helena Laboratories
Immunology · 102d
Cleared Nov 02, 1992
SYVA EMIT II PROPOXYPHENE ASSAY
K923873 · JXN
Syva Co.
Toxicology · 91d
Cleared Nov 02, 1992
ACCUTEX IM RBC TEST
K924037 · KTN
J.S. Medical Assoc.
Immunology · 83d
Cleared Nov 02, 1992
SUB-4 SMALL VESSEL BALLOON DILATATION CATHETER
K924047 · LIT
Boston Scientific Corp
Cardiovascular · 83d
Cleared Nov 02, 1992
KALESTAD ANA MICROPLATE EIA
K924087 · LJM
Bio-Rad Laboratories, Inc.
Immunology · 81d
Cleared Nov 02, 1992
ACCUTEX SLE LATEX TEST
K924248 · LJM
J.S. Medical Assoc.
Immunology · 70d
Cleared Nov 02, 1992
STC DIAGNOSTICS AUTO-LYTE(TM) PCP EIA
K924462 · LCM
Solarcare Technologies Corp,Inc.
Toxicology · 61d
Cleared Nov 02, 1992
CEFPODOXIME 10 MCG, SENSI DISC
K924797 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 39d
Cleared Oct 30, 1992
VSI 1000
K912921 · FMT
Vitaltrends Technology, Inc.
General Hospital · 485d
Cleared Oct 30, 1992
BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP
K915580 · DSP
Belmont Instrument Corp.
Cardiovascular · 339d
Cleared Oct 30, 1992
KINAMED 26MM BIOCERAN-Z TOTAL HIP FEMORAL BALL
K920219 · LZO
Kinamed, Inc.
Orthopedic · 288d
Cleared Oct 30, 1992
VIBROTACTILE TESTER, MODEL NO. VTT-100
K921560 · LLN
Topical Testing, Inc.
Neurology · 212d
Cleared Oct 30, 1992
CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR
K921936 · JXG
Cordis Corp.
Neurology · 189d
Cleared Oct 30, 1992
BARD BIOPSY FORCEPS
K922086 · GCL
C.R. Bard, Inc.
Gastroenterology & Urology · 179d
Cleared Oct 30, 1992
NASOGRASTRIC TUBBE HOLDER
K922209 · KNT
Innovative Medical Design Corp.
Gastroenterology & Urology · 171d
Cleared Oct 30, 1992
DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED
K922479 · BZO
Intertech Resources, Inc.
Anesthesiology · 157d
Cleared Oct 30, 1992
ATRAUM WOUND DRESSING--MODIFICATION
K922760 · KMF
Axiom Medical, Inc.
General & Plastic Surgery · 155d