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
88489–88512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1998
TUMOR MARKER CONTROL
K982473 · JJY
Diagnostic Products Corp.
Immunology · 27d
Cleared Aug 12, 1998
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
K982619 · CCL
Hewlett-Packard Co.
Anesthesiology · 16d
Cleared Aug 12, 1998
IMMULITE PSA CONTROL MODULE, MODEL LPSCM
K982637 · JJY
Diagnostic Products Corp.
Immunology · 14d
Cleared Aug 12, 1998
VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III
K982649 · DIF
Ortho-Clinical Diagnostics, Inc.
Chemistry · 13d
Cleared Aug 12, 1998
MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR
K982697 · DSI
Mennen Medical, Inc.
Cardiovascular · 9d
Cleared Aug 11, 1998
BONETRAP
K980049 · EIA
Bladhs Plast AB
Dental · 217d
Cleared Aug 11, 1998
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K980453 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 187d
Cleared Aug 11, 1998
MYELOTEC VIDEO GUIDED CATHETER
K980734 · HRX
Myelotec, Inc.
Orthopedic · 167d
Cleared Aug 11, 1998
RETROGRADE PEDIATRIC NAIL
K980854 · HTY
Encore Orthopedics, Inc.
Orthopedic · 159d
Cleared Aug 11, 1998
VICHY SHOWER
K980909 · ILJ
Bouvier Hydro, Inc.
Physical Medicine · 154d
Cleared Aug 11, 1998
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
K981681 · KDI
Gambro Healthcare
Gastroenterology & Urology · 90d
Cleared Aug 11, 1998
BREATHAID TONGUE SCRAPER
K981808 · LCN
Breathaid, LLC
Dental · 82d
Cleared Aug 11, 1998
OPERATING ROOM TOWELS
K981823 · KKX
Baldur Systems Corp.
General Hospital · 81d
Cleared Aug 11, 1998
PRO-FLEX DISPOSABLE PROPHY ANGLE
K981869 · EFB
Professional Dental Mfg., Inc.
Dental · 75d
Cleared Aug 11, 1998
NITRILE POWDERFREE EXAMINATION GLOVES
K981877 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 75d
Cleared Aug 11, 1998
POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981878 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 75d
Cleared Aug 11, 1998
POWDERED NITRILE EXAMINATION GLOVES
K981879 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 75d
Cleared Aug 11, 1998
SELECTOR DIAGNOSTIC CATHETER
K982077 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 60d
Cleared Aug 11, 1998
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE
K982274 · LZA
Asia Pacific Latex Sdn Bhd
General Hospital · 43d
Cleared Aug 11, 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
K982286 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 42d
Cleared Aug 11, 1998
BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW
K982398 · JDC
Biomet, Inc.
Orthopedic · 32d
Cleared Aug 11, 1998
SCC-23 SAFETY CLAMP AND CUTTER
K982464 · KNA
Women First Healthcare, Inc.
Obstetrics & Gynecology · 27d
Cleared Aug 11, 1998
DEROYAL INDUSTRIES, INC. DEFOGGER
K982465 · OCT
Deroyal Industries, Inc.
Gastroenterology & Urology · 27d
Cleared Aug 11, 1998
LATEX EXAMINATION GLOVES POWDER FREE
K982579 · LYY
Shiva Medicare , Ltd.
General Hospital · 18d