FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84313–84336 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 1999
DASH 3000 PATIENT MONITOR
K992929 · MHX
General Electric Medical Systems...
Cardiovascular · 87d
Cleared Nov 26, 1999
CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
K992965 · DRF
Cordis Webster, Inc.
Cardiovascular · 85d
Cleared Nov 26, 1999
MODIFICATION TO DOCUMENT THYROID CAL.VER
K993014 · JJY
Casco-Nerl Diagnostics Corporation...
Immunology · 79d
Cleared Nov 26, 1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
K993023 · JJY
Beckman Coulter, Inc.
Immunology · 78d
Cleared Nov 26, 1999
CD-CHEX CD 34
K993126 · GGL
Streck Laboratories, Inc.
Hematology · 67d
Cleared Nov 26, 1999
PRIMUS
K993425 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Nov 26, 1999
SYNCHRON SYSTEMS DRUG CALIBRATOR 2
K993473 · DLJ
Beckman Coulter, Inc.
Toxicology · 43d
Cleared Nov 26, 1999
VARELISA RNP ANTIBODIES
K993589 · LKO
Pharmacia & Upjohn Co.
Immunology · 35d
Cleared Nov 26, 1999
K-ASSAY APO A1/B CALIBRATOR SET
K993606 · JIX
Kamiya Biomedical Co.
Chemistry · 32d
Cleared Nov 26, 1999
KAC-300 KNEE ARRAY COIL
K993719 · MOS
Mri Devices Corp.
Radiology · 23d
Cleared Nov 26, 1999
MEDRAD ENVISION CT INJECTOR SYSTEM
K993728 · DXT
Medrad, Inc.
Cardiovascular · 22d
Cleared Nov 26, 1999
MAMEX
K993740 · IZH
Medical Systems Group
Radiology · 22d
Cleared Nov 26, 1999
QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)
K993763 · IZI
Medis Medical Imaging Systems BV
Radiology · 18d
Cleared Nov 26, 1999
QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)
K993765 · IZI
Medis Medical Imaging Systems BV
Radiology · 18d
Cleared Nov 26, 1999
QSC-300 SHOULDER ARRAY COILS
K993780 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Nov 24, 1999
IGA MININEPH ANTISERUM
K981786 · CFQ
The Binding Site, Ltd.
Immunology · 553d
Cleared Nov 24, 1999
ABL 735 ANALYZER
K991417 · CHL
Radiometer America, Inc.
Chemistry · 215d
Cleared Nov 24, 1999
NEW MULTIPLES REAGENT STRIPS
K992257 · JIR
Bayer Corp.
Chemistry · 141d
Cleared Nov 24, 1999
OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT...
K992264 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 141d
Cleared Nov 24, 1999
AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
K992449 · MID
Cogent Diagnotics , Ltd.
Immunology · 125d
Cleared Nov 24, 1999
MODUS 2.5 MANDIBULAR RECONSTRUCTION SET
K992682 · JEY
Medartis AG
Dental · 106d
Cleared Nov 24, 1999
MODUS 2.5 MANDIBULAR TRAUMA SET
K992683 · JEY
Medartis AG
Dental · 106d
Cleared Nov 24, 1999
ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK
K992710 · JJY
Abbott Laboratories
Immunology · 105d
Cleared Nov 24, 1999
GEM PREMIER 3000
K992834 · CHL
Instrumentation Laboratory CO
Chemistry · 93d