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

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176,076 results
55753–55776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2008
MLCI2
K082122 · IYE
Elekta , Ltd.
Radiology · 32d
Cleared Aug 29, 2008
MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM
K082186 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 28d
Cleared Aug 29, 2008
DEPUY C-STEM AMT
K082239 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 22d
Cleared Aug 29, 2008
DSA 2000EX
K082341 · LLZ
Eigen, LLC
Radiology · 14d
Cleared Aug 29, 2008
NORAS MR-BI320-PA 3T
K082373 · MOS
Noras Mri Products GmbH
Radiology · 11d
Cleared Aug 28, 2008
REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C
K071023 · GDW
Reach Surgical, Inc.
General & Plastic Surgery · 505d
Cleared Aug 28, 2008
SILVER ANTIMICROBIAL WOUND GEL
K073197 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 289d
Cleared Aug 28, 2008
SYGNAL DBM
K080405 · MBP
Musculoskeletal Transplant Foundation
Orthopedic · 196d
Cleared Aug 28, 2008
CENTURION PROTECTIVE RESTRAINT, SCR SERIES
K080448 · FMQ
Tri-State Hospital Supply Corp.
General Hospital · 191d
Cleared Aug 28, 2008
OPACITY + BONE CEMENT
K080873 · NDN
Teknimed, S.A.
Orthopedic · 150d
Cleared Aug 28, 2008
CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX
K081361 · FPA
Icu Medical, Inc.
General Hospital · 105d
Cleared Aug 28, 2008
STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES
K081464 · LYY
Cardinalhealth
General Hospital · 93d
Cleared Aug 28, 2008
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
K081488 · LYY
Pt. Maja Agung Latexindo
General Hospital · 92d
Cleared Aug 28, 2008
BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO
K081550 · ELC
Bonart Co., Ltd.
Dental · 86d
Cleared Aug 28, 2008
GENESIS
K081559 · GEI
Medisiss
General & Plastic Surgery · 86d
Cleared Aug 28, 2008
BAHA INTENSO
K081606 · LXB
Cochlear Americas
Ear, Nose, Throat · 83d
Cleared Aug 28, 2008
CLAROS NANO DENTAL LASER SYSTEM
K081652 · GEX
Elexxion AG
General & Plastic Surgery · 77d
Cleared Aug 28, 2008
INOMAX DS (DELIVERY SYSTEM)
K081691 · MRN
Ino Therapeutics, LLC
Anesthesiology · 72d
Cleared Aug 28, 2008
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
K081849 · OVD
Blackstone Medical, Inc.
Orthopedic · 59d
Cleared Aug 28, 2008
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
K082132 · HQC
Bausch & Lomb, Inc.
Ophthalmic · 30d
Cleared Aug 28, 2008
LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002
K082194 · HRX
Laurimed, LLC
Orthopedic · 24d
Cleared Aug 28, 2008
POWERLOC CLEAR SAFETY INFUSION SET
K082306 · FPA
C.R. Bard, Inc.
General Hospital · 15d
Cleared Aug 28, 2008
ARTHROCARE ARTHROWANDS
K082323 · GEI
Arthrocare Corp.
General & Plastic Surgery · 14d
Cleared Aug 28, 2008
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K082356 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 10d