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
66841–66864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2005
SYSTEM 7500-B ELECTROSURGICAL UNIT
K050161 · GEI
Conmed Electrosurgery
General & Plastic Surgery · 9d
Cleared Feb 02, 2005
59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS
K040303 · LPL
Hydrogel Vision Corporation
Ophthalmic · 359d
Cleared Feb 02, 2005
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246 · KXK
C.R. Bard, Inc.
Radiology · 71d
Cleared Feb 02, 2005
CERVEX-BRUSH COMBI
K043369 · HHT
Rovers Medical Devices B.V.
Obstetrics & Gynecology · 56d
Cleared Feb 02, 2005
GE LOGIQ TWIN
K050126 · IYN
General Electric Co.
Radiology · 14d
Cleared Feb 01, 2005
GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS
K031782 · KWQ
Medtronic Sofamor Danek
Orthopedic · 602d
Cleared Feb 01, 2005
UPDATED SLIP UROLOGY INTRODUCER SHEATH
K042531 · KNY
Percutaneous Systems, Incorporated
Gastroenterology & Urology · 137d
Cleared Feb 01, 2005
TESCERA OPAQUER POWDER/SCULPTING RESIN
K042804 · EBF
Bisco, Inc.
Dental · 112d
Cleared Feb 01, 2005
COOLTOUCH, MODEL CT3S
K043046 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 89d
Cleared Feb 01, 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043151 · KWQ
Medtronic Sofamor Danek
Orthopedic · 78d
Cleared Feb 01, 2005
VERTEBRON PSS PEDICLE SCREW SYSTEM
K043152 · MNH
Vertebron, Inc.
Orthopedic · 78d
Cleared Feb 01, 2005
BISCOVER LV
K043168 · EBD
Bisco, Inc.
Dental · 77d
Cleared Feb 01, 2005
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
K043233 · HSB
Efratgo, Ltd. HI Tech Bio-Surgical
Orthopedic · 71d
Cleared Feb 01, 2005
NOBELRONDO DENTAL CERAMIC - ZIRCONIA
K043312 · EIH
Nobel Biocare USA, LLC
Dental · 62d
Cleared Feb 01, 2005
D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY...
K043323 · DTZ
Dideco S.R.L.
Cardiovascular · 61d
Cleared Feb 01, 2005
VITELCARE TURTLE, MODEL 400
K043368 · MWI
Visual Telecommunications Network, Inc.
Cardiovascular · 55d
Cleared Feb 01, 2005
MODEL SC-3008 SEQUENTIAL CIRCULATOR
K043423 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 50d
Cleared Feb 01, 2005
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K043475 · LYZ
Shijiazhuang Winful Plastic Co., Ltd.
General Hospital · 47d
Cleared Feb 01, 2005
HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES
K043540 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 41d
Cleared Feb 01, 2005
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
K050067 · HIL
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 20d
Cleared Feb 01, 2005
LERADO AVANTICARE POWER WHEELCHAIR, MODEL PW-1800
K050087 · ITI
Lerado Oversea Ltd. Twn Branch (Bvi)
Physical Medicine · 19d
Cleared Feb 01, 2005
E-Z PEN, REUSEABLE HANDSWITCHING PENCIL
K050102 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 14d
Cleared Feb 01, 2005
OMNIPRO SYSTEM
K050143 · OLV
Mays and Associates, Inc.
Neurology · 11d
Cleared Jan 31, 2005
ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
K041630 · MCW
Cardiovascular Systems Incorporated
Cardiovascular · 229d