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
75865–75888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2002
DUET SUTURE ANCHOR
K020056 · HWC
Bionx Implants, Ltd.
Orthopedic · 169d
Cleared Jun 26, 2002
BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K020974 · CBF
Environmental Tectonics Corp.
Anesthesiology · 92d
Cleared Jun 26, 2002
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
K021034 · KNT
Tfx Medical, Inc.
Gastroenterology & Urology · 89d
Cleared Jun 26, 2002
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
K021036 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 86d
Cleared Jun 26, 2002
ERA IMPLANT
K021045 · DZE
Sterngold
Dental · 86d
Cleared Jun 26, 2002
KSEA NEUROENDOSCOPES AND ACCESSORIES
K021050 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 86d
Cleared Jun 26, 2002
SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM
K021137 · KNW
Sanarus Medical, Inc.
Gastroenterology & Urology · 78d
Cleared Jun 26, 2002
JUMP START, MODEL 970300
K021168 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 76d
Cleared Jun 26, 2002
MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM
K021211 · GEH
Sanarus Medical, Inc.
General & Plastic Surgery · 70d
Cleared Jun 26, 2002
BELIMED STEAM STERILIZER, MODEL TOP 5000
K021223 · FLE
Sauter AG
General Hospital · 69d
Cleared Jun 26, 2002
SOFTLASE G2-SURGICAL DIODE LASER SYSTEM
K021227 · GEX
Zap Lasers, LLC
General & Plastic Surgery · 69d
Cleared Jun 26, 2002
WARMER 2000LD
K021289 · LHC
O.R. Solutions, Inc.
General Hospital · 64d
Cleared Jun 26, 2002
CONMED HEATWAVE HAND-CONTROLLED ELETRODE
K021299 · GEI
Conmedcorp
General & Plastic Surgery · 63d
Cleared Jun 26, 2002
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K021684 · JEY
Bioplate, Inc.
Orthopedic · 35d
Cleared Jun 26, 2002
AUTOPAL 50
K021733 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 29d
Cleared Jun 26, 2002
CRITERTION, MODEL #1067511
K021741 · EJT
Sterngold
Dental · 29d
Cleared Jun 26, 2002
T2 FEMORAL NAIL
K021744 · HSB
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jun 26, 2002
ENDIUS ATAVI SYSTEM
K021748 · HRX
Endius, Inc.
Orthopedic · 29d
Cleared Jun 26, 2002
CEMENTED FEMORAL HEAD RESURFING DEVICE
K021799 · KXA
Biomet Orthopedics, Inc.
Orthopedic · 26d
Cleared Jun 26, 2002
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
K021832 · HWC
Biomet, Inc.
Orthopedic · 22d
Cleared Jun 26, 2002
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)
K021879 · MNH
Depuyacromed
Orthopedic · 19d
Cleared Jun 26, 2002
CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)
K021880 · MNH
Depuyacromed
Orthopedic · 19d
Cleared Jun 25, 2002
UHI-3 HIGH FLOW INSUFFLATION UNIT
K014166 · HIF
Olympus Optical Co., Ltd.
Obstetrics & Gynecology · 188d
Cleared Jun 25, 2002
ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
K020296 · EWD
Apothecary Products, Inc.
Ear, Nose, Throat · 148d