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
92401–92424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1997
KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
K971977 · FBN
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared Aug 12, 1997
KARL STORZ MODEL 203020 20 EQUIMAT
K971982 · LJH
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared Aug 12, 1997
VISUALINE II METHAMPHETIMINE
K972032 · DKZ
Sun Biomedical Laboratories, Inc.
Toxicology · 71d
Cleared Aug 12, 1997
ACCURUN 117 HBEAG POSITIVE CONTROL
K972048 · JJY
Boston Biomedica, Inc.
Microbiology · 71d
Cleared Aug 12, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
K972086 · BZK
Alexander Mfg. Co.
Anesthesiology · 69d
Cleared Aug 12, 1997
ALTA INTRAMEDULLARY ROD SYSTEM
K972108 · HSB
Howmedica Corp.
Orthopedic · 68d
Cleared Aug 12, 1997
CHLAMYDIATROL AG
K972129 · MJZ
Blackhawk Biosystems, Inc.
Microbiology · 67d
Cleared Aug 12, 1997
SPECTROLYSE HEPARIN (ANTI-IIA)
K972209 · KFF
Medical Diagnostic Technologies, Inc.
Hematology · 62d
Cleared Aug 12, 1997
PRECICONTROL TUMOR MARKER 1 AND 2
K972235 · JJY
Boehringer Mannheim Corp.
Immunology · 57d
Cleared Aug 12, 1997
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K972250 · JFJ
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Aug 12, 1997
TOOL-LESS WHEEL CHAIR
K972797 · IOR
Sunrise Medical, Inc.
Physical Medicine · 15d
Cleared Aug 11, 1997
ANODYNE CC
K963481 · BSZ
Heyer America, Inc.
Anesthesiology · 342d
Cleared Aug 11, 1997
ZIP CONDOM CATHETER
K964219 · EYZ
Goulter Medical, Inc.
Gastroenterology & Urology · 293d
Cleared Aug 11, 1997
ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)
K964431 · LZO
Biomet, Inc.
Orthopedic · 279d
Cleared Aug 11, 1997
QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM
K964444 · HSB
Rdh Medical
Orthopedic · 278d
Cleared Aug 11, 1997
ARRHYTHMIA MAPPING SYSTEM (8100/8300)
K965066 · DRF
Cardiac Pathways Corp.
Cardiovascular · 236d
Cleared Aug 11, 1997
PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
K970145 · HIR
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 208d
Cleared Aug 11, 1997
FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
K971305 · HIH
Gynecare Innovation Center
Obstetrics & Gynecology · 125d
Cleared Aug 11, 1997
OSTEO KIRSCHNER WIRES
K971962 · HTY
Osteonics Corp.
Orthopedic · 75d
Cleared Aug 11, 1997
COHEN DISTRACTOR
K972154 · JEY
Howmedica Leibinger, Inc.
Dental · 63d
Cleared Aug 11, 1997
GUERRERO - BELL DISTRACTOR
K972166 · JEY
Howmedica Leibinger, Inc.
Dental · 63d
Cleared Aug 11, 1997
METAGEN ACTIVELOCK CERCLAGE SYSTEM
K972327 · JDQ
Pacific Materials and Interfaces
Orthopedic · 49d
Cleared Aug 11, 1997
LORENZ PECTUS SUPPORT BAR
K972420 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 45d
Cleared Aug 11, 1997
MVM 3.3 MM MICROENDOSCOPE
K972504 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 39d