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
153361–153384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1984
IMPLANTABLE ELECTRODE BIPOLAR ADAPT
K840025 · DTD
Telectronics, Inc.
Cardiovascular · 139d
Cleared May 23, 1984
IMPLANTABLE ELECTRODE UNIPOLAR ADAPT
K840026 · DTD
Telectronics, Inc.
Cardiovascular · 139d
Cleared May 23, 1984
TEC-3500 DEFIBRILLATOR
K840258 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 121d
Cleared May 23, 1984
EMERGENCY INFUSION DEVICE
K840455 · DYB
Arrow Intl., Inc.
Cardiovascular · 111d
Cleared May 23, 1984
WALDMANN SUNTANNING EQUIP-MODELS'S
K840555
Eurotan Intl.
General & Plastic Surgery · 105d
Cleared May 23, 1984
HEPARIN COATED THERMODILUTION CATHETERS
K840824 · KRB
Gould, Inc.
Cardiovascular · 89d
Cleared May 23, 1984
THERMODILUTION CATHETER
K840992 · KRB
Gould, Inc.
Cardiovascular · 77d
Cleared May 23, 1984
OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT
K841031 · DTN
American Bentley
Cardiovascular · 72d
Cleared May 23, 1984
HUCKSTEPS STAPLES
K841125
Downs Surgical , Ltd.
Orthopedic · 69d
Cleared May 23, 1984
BEAR 33
K841279 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 56d
Cleared May 23, 1984
REESE OSTEOTOMY GUIDE SYS
K841470 · HTH
Osteotomy Guide Co.
Orthopedic · 44d
Cleared May 23, 1984
ARTERIAL BLOOD SAMPLING KITS
K841486 · CBT
Concord Laboratories, Inc.
Anesthesiology · 43d
Cleared May 23, 1984
SIEMENS-ELEMA VENTILATOR 900C
K841529 · CBK
Siemens Elema AB
Anesthesiology · 40d
Cleared May 23, 1984
TRIPLE LUMEN INFUSION CATHETER/ACCESS
K841535
Gish Biomedical, Inc.
Cardiovascular · 86d
Cleared May 23, 1984
PATIENT TUBING HYTREL SIEMENS-ELEMA
K841657 · BZO
Siemens Elema AB
Anesthesiology · 30d
Cleared May 23, 1984
INNOFLUOR PHENOBARBITAL
K841707 · LGQ
Innotron Diagnostics
Toxicology · 30d
Cleared May 23, 1984
D.L. SCOPE BLADE & HANDLE
K841778 · CCW
North American Medical Products, Inc.
Anesthesiology · 23d
Cleared May 23, 1984
ALPHA PUSH KART
K841911 · INM
Alpha Unlimited, Inc.
Physical Medicine · 14d
Cleared May 23, 1984
ALPHA 4 X 4
K841912 · ITI
Alpha Unlimited, Inc.
Physical Medicine · 14d
Cleared May 23, 1984
ALPHA TRI-KART
K841919 · INI
Alpha Unlimited, Inc.
Physical Medicine · 13d
Cleared May 23, 1984
MAC-MULTI-ADJUSTABLE CHAIR
K841920 · IPL
Alpha Unlimited, Inc.
Physical Medicine · 13d
Cleared May 23, 1984
ALPHA PLUS 1
K841921 · ITI
Alpha Unlimited, Inc.
Physical Medicine · 13d
Cleared May 23, 1984
OASIS CLUB HYDROMASSAGE
K841954 · ILJ
Prexcor America, Inc.
Physical Medicine · 9d
Cleared May 23, 1984
EZY-RAMP
K841994
Ezy-Ramp Co.
Physical Medicine · 8d