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
81025–81048 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 2000
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
K002509 · MUJ
Brainlab AG
Radiology · 80d
Cleared Nov 03, 2000
PILLING E-FRAZIER BIPOLAR SUCTION TUBE
K002582 · GEI
Pilling
General & Plastic Surgery · 77d
Cleared Nov 03, 2000
KSEA MINIATURE NEUROENDOSCOPE
K002704 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 65d
Cleared Nov 03, 2000
3D ENDOSCOPE
K002924 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 45d
Cleared Nov 03, 2000
PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE
K003019 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 37d
Cleared Nov 03, 2000
HERMES PORT EXPANDER
K003217 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 21d
Cleared Nov 03, 2000
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K003222 · GCI
Computer Motion, Inc.
General & Plastic Surgery · 18d
Cleared Nov 03, 2000
RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE
K003233 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 17d
Cleared Nov 03, 2000
BIOMET LATERAL TROCH PLATE
K003294 · JDW
Biomet, Inc.
Orthopedic · 14d
Cleared Nov 02, 2000
QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3
K001249 · JJY
Consolidated Technologies of Wisconsin
Chemistry · 204d
Cleared Nov 02, 2000
ACCUWELL TSH, MODEL KAW-TSH-960
K001455 · JLW
Neometrics, Inc.
Chemistry · 177d
Cleared Nov 02, 2000
OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL...
K001676 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 154d
Cleared Nov 02, 2000
SIMPLICITY SPINAL SYSTEM
K002103 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 113d
Cleared Nov 02, 2000
QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H
K002390 · JFB
Lsi Intl., Inc.
Physical Medicine · 90d
Cleared Nov 02, 2000
VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
K002392 · GWM
Integra Neurocare, LLC
Neurology · 87d
Cleared Nov 02, 2000
MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
K002456 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 84d
Cleared Nov 02, 2000
HARDYDISK CLINDAMYCIN, 2MCG
K002662 · JTN
Hardy Diagnostics
Microbiology · 69d
Cleared Nov 02, 2000
R&D PROJECT DW271#11A
K002872 · EJT
Ivoclar North America, Inc.
Dental · 49d
Cleared Nov 02, 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
K003112 · JJX
Ortho-Clinical Diagnostics, Inc.
Microbiology · 29d
Cleared Nov 02, 2000
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
K003131 · JDW
Biomet, Inc.
Orthopedic · 27d
Cleared Nov 02, 2000
RETINADX
K003236 · HKI
Regulatory Associates, Inc.
Ophthalmic · 16d
Cleared Nov 01, 2000
CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM
K001948 · DXN
Hypertension Diagnostics, Inc.
Cardiovascular · 128d
Cleared Nov 01, 2000
SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)
K002362 · MQV
Synthes (Usa)
Orthopedic · 90d
Cleared Nov 01, 2000
MEDOVATIONS ESOPHAGEAL DILATOR
K002363 · KNQ
Medovations, Inc.
Gastroenterology & Urology · 90d