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
80353–80376 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2001
HORIZONS PAPILLOTOME
K002236 · KNS
Horizons Intl. Corp.
Gastroenterology & Urology · 183d
Cleared Jan 23, 2001
MEDLINE STERILIZATION WRAP
K002968 · FRG
Medline Industries, Inc.
General Hospital · 123d
Cleared Jan 23, 2001
ALGINATE IMPRESSION MATERIAL
K003426 · ELW
Rite-Dent Manufacturing Corp.
Dental · 81d
Cleared Jan 23, 2001
DIFFUSION TENSOR IMAGING OPTION
K003573 · LNH
Ge Medical Systems, Inc.
Radiology · 64d
Cleared Jan 23, 2001
MAGNETOM RHAPSODY SYSTEM
K003628 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 60d
Cleared Jan 23, 2001
VITREA 2 CT PERFUSION OPTION
K003639 · JAK
Vital Images, Inc.
Radiology · 60d
Cleared Jan 23, 2001
CAVEX TEMPORARY CEMENT
K003791 · EMA
Cavex Holland BV
Dental · 46d
Cleared Jan 23, 2001
GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K003872 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 39d
Cleared Jan 23, 2001
MOLINA ORBITAL MALAR DISTRACTOR
K003883 · JEY
KLS-Martin L.P.
Dental · 39d
Cleared Jan 23, 2001
RITA STARBURST XLI ELECTROSURGICAL DEVICE
K010060 · GEI
Rita Medical Systems
General & Plastic Surgery · 15d
Cleared Jan 22, 2001
GLUTARTEST 1 REAGENT STRIP
K002011 · MSY
Integrated Biomedical Technology, Inc.
Gastroenterology & Urology · 203d
Cleared Jan 22, 2001
GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
K002621 · CGA
Apex BioTechnology Corp.
Chemistry · 152d
Cleared Jan 22, 2001
GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM
K002624 · CGA
Apex BioTechnology Corp.
Chemistry · 152d
Cleared Jan 22, 2001
INSTACCULT
K002930 · KHE
Medtek Diagnostics, LLC
Hematology · 124d
Cleared Jan 22, 2001
V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A...
K003042 · LPL
Joe B. Goldberg, O.D.
Ophthalmic · 115d
Cleared Jan 22, 2001
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
K003323 · FTL
Davol, Inc.
General & Plastic Surgery · 90d
Cleared Jan 22, 2001
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
K003341 · KLB
Syva Co., Dade Behring, Inc.
Chemistry · 89d
Cleared Jan 22, 2001
WAKO CRP-UL, CRP-UL CALIBRATOR SET
K003342 · DCN
Wako Chemicals USA, Inc.
Chemistry · 89d
Cleared Jan 22, 2001
PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
K003459 · LLZ
Philips Medical Systems North...
Radiology · 76d
Cleared Jan 22, 2001
NARKOMED MRI-2, MODEL NM-MRI-2
K003579 · BSZ
Draeger Medical, Inc.
Anesthesiology · 63d
Cleared Jan 22, 2001
VIEW READING STATION
K003688 · LLZ
Electromed Intl., Ltd.
Radiology · 53d
Cleared Jan 22, 2001
ADVANTAGE THC/COCAINE TEST
K003708 · DIO
Advantage Diagnostics Corp.
Toxicology · 52d
Cleared Jan 22, 2001
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
K003959 · LJM
Inova Diagnostics, Inc.
Immunology · 32d
Cleared Jan 22, 2001
CONTOUR POLARIS URETERAL STENT
K010002 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 20d