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
88993–89016 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1998
D903 AVANT ADULT HOLLOW FIBER OXYGENATOR
K980600 · JOW
Dideco S.P.A.
Cardiovascular · 176d
Cleared Aug 12, 1998
BETTER-BLADDER (BB)
K981284 · DTN
Circulatory Technology, Inc.
Cardiovascular · 126d
Cleared Aug 12, 1998
ACS:CENTAUR CEA
K981478 · DHX
Chiron Diagnostics Corp.
Immunology · 110d
Cleared Aug 12, 1998
KSEA UNIMAT 45
K981703 · BTA
Karl Storz Endoscopy
General & Plastic Surgery · 90d
Cleared Aug 12, 1998
LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT...
K981782 · DYB
Arrow Intl., Inc.
Cardiovascular · 84d
Cleared Aug 12, 1998
ACS:CENTAUR PSA2 IMMUNOASSAY
K981839 · LTJ
Chiron Diagnostics Corp.
Immunology · 78d
Cleared Aug 12, 1998
STERILE SILICONE EXTERNAL WOUND COVER
K982065 · MIB
Specialty Surgical Products, Inc.
General & Plastic Surgery · 61d
Cleared Aug 12, 1998
MICROALBUSTIX REAGENT STRIPS
K982219 · JIR
Bayer Corp.
Chemistry · 49d
Cleared Aug 12, 1998
MARKWELL GAUZE SPONGE
K982260 · LWH
Markwell Intl., Inc.
General & Plastic Surgery · 47d
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