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
84241–84264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1999
FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM...
K990401 · IYO
Fukuda Denshi USA, Inc.
Radiology · 248d
Cleared Oct 15, 1999
DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE
K990750 · LZA
Wrp Specialty Products Sdn. Bhd.
General Hospital · 221d
Cleared Oct 15, 1999
LUMA-CATH FIXED CURVE EP CATHETERS
K991025 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 200d
Cleared Oct 15, 1999
IRRIGATION OR INFUSION PUMP K PUMP
K991203 · FRN
Kmi Kolster Methods, Inc.
General Hospital · 190d
Cleared Oct 15, 1999
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
K992394 · HSD
Endotec, Inc.
Orthopedic · 88d
Cleared Oct 15, 1999
ACTITRAC
K992410 · GWQ
Individual Monitoring Systems, Inc.
Neurology · 87d
Cleared Oct 15, 1999
PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE
K992416 · LYC
Usbiomaterials Corp.
Dental · 87d
Cleared Oct 15, 1999
BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER
K992435 · EFW
Azo Enterprises
Dental · 85d
Cleared Oct 15, 1999
KSEA SCBCOM
K992469 · FET
Karl Storz Endoscopy
Gastroenterology & Urology · 81d
Cleared Oct 15, 1999
PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K992478 · DXN
Hewlett-Packard, Healthcare Solutions...
Cardiovascular · 81d
Cleared Oct 15, 1999
ABX PENTRA 60 HEMATOLOGY ANALYZER
K992511 · GKZ
Abx Diagnostics
Hematology · 80d
Cleared Oct 15, 1999
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
K992591 · GWM
Codman & Shurtleff, Inc.
Neurology · 74d
Cleared Oct 15, 1999
MODIFICATION TO INTRASTENT
K992816 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 56d
Cleared Oct 15, 1999
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100...
K992870 · LYY
Alliance Rubber Products Sdn. Bhd.
General Hospital · 50d
Cleared Oct 15, 1999
ANTI-TISSUE TRANSGLUTAMINASE (TTG)ANTIBODY TEST
K992878 · MVM
Immco Diagnostics, Inc.
Immunology · 50d
Cleared Oct 15, 1999
STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA
K993148 · FYA
Stryker Instruments
General Hospital · 24d
Cleared Oct 15, 1999
OBC-085 BREAST ARRAY COIL
K993233 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Oct 15, 1999
QWH-085 WRIST ARRAY COIL
K993235 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Oct 15, 1999
QSC-085 SHOULDER ARRAY COIL
K993279 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Oct 14, 1999
ZIPPY
K983808 · ITI
Pillar Technology, Inc.
Physical Medicine · 351d
Cleared Oct 14, 1999
MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY
K990372 · HET
Dr. Fritz GmbH
Obstetrics & Gynecology · 248d
Cleared Oct 14, 1999
CONTOUR SPINAL SYSTEM
K990986 · KWP
Ortho Development Corp.
Orthopedic · 204d
Cleared Oct 14, 1999
SIMPLICARE TRANSPARENT WOUND DRESSING
K991214 · MGP
Hollister, Inc.
General & Plastic Surgery · 188d
Cleared Oct 14, 1999
ECOMED SCALP VEIN SET
K992145 · FPA
Greiner Meditech, Inc.
General Hospital · 112d