Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
64489–64512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 2005
UNI-VENT MODEL 73X
K051476 · BTL
Impact Instrumentation, Inc.
Anesthesiology · 147d
Cleared Oct 28, 2005
BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)
K052028 · ELC
Bonart Co., Ltd.
Dental · 93d
Cleared Oct 28, 2005
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
K052112 · IKN
Excel Tech. , Ltd.
Neurology · 85d
Cleared Oct 28, 2005
RESPCARE FACE MASK
K052227 · BZD
Respcare, Inc.
Anesthesiology · 73d
Cleared Oct 28, 2005
CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000
K052473 · IYX
Inter Medical Medizintechnik GmbH
Radiology · 49d
Cleared Oct 28, 2005
MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER
K052713 · CBF
Sechrist Industries, Inc.
Anesthesiology · 29d
Cleared Oct 28, 2005
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
K052747 · NKB
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Oct 28, 2005
PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K052757 · LIT
Biotronik AG
Cardiovascular · 28d
Cleared Oct 28, 2005
STARSPEED SERIES CT SCANNER SYSTEMS
K052855 · JAK
Ge Healthcare
Radiology · 17d
Cleared Oct 28, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
K052982 · JIT
Roche Diagnostics
Chemistry · 4d
Cleared Oct 27, 2005
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH...
K043341 · NVI
Bio-Rad Laboratories, Inc.
Immunology · 328d
Cleared Oct 27, 2005
N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
K043383 · FBK
Physion, Inc.
Gastroenterology & Urology · 322d
Cleared Oct 27, 2005
VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
K051248 · DYB
Vygon Corp.
Cardiovascular · 164d
Cleared Oct 27, 2005
STOMA BONE SCREW
K051871 · DZL
Storz AM Mark GmbH
Dental · 108d
Cleared Oct 27, 2005
MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT
K052191 · NQI
Veridex, LLC
Pathology · 77d
Cleared Oct 27, 2005
QUANTA LITE M2 EP (MIT3) ELISA
K052262 · DBM
Inova Diagnostics, Inc.
Immunology · 69d
Cleared Oct 27, 2005
VCS, MODEL S4T
K052558 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 41d
Cleared Oct 27, 2005
ORTHOPEDIC SALVAGE SYSTEM- OSS
K052685 · KRO
Biomet, Inc.
Orthopedic · 29d
Cleared Oct 27, 2005
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
K052718 · LZO
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Oct 27, 2005
MINXRAY, MODEL HF100H+
K052721 · IZL
Minxray, Inc.
Radiology · 28d
Cleared Oct 27, 2005
WRIST FUSION PLATE
K052754 · LXT
Dvo Extremity Solutions, LLC
Orthopedic · 27d
Cleared Oct 27, 2005
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
K052783 · DQX
Boston Scientific Corp
Cardiovascular · 24d
Cleared Oct 27, 2005
FOURSIGHT VIEWTOOL IMAGE VIEWER
K052895 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared Oct 27, 2005
VIRTUAL MEDICAL SYSTEMS MODEL VT3000
K052904 · JXE
Scientific Imaging, Inc.
Neurology · 13d