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
53497–53520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2009
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19
K090665 · NTE
Abbott Vascular-Vascular Solutions
Cardiovascular · 70d
Cleared May 22, 2009
MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
K090676 · EFA
Anthogyr
Dental · 70d
Cleared May 22, 2009
C-PORT - HP POWER INJECTABLE PORT
K091099 · LJT
Phs Medical GmbH
General Hospital · 36d
Cleared May 22, 2009
DIAGNOSTIC CATHETER SYSTEM
K091250 · EOQ
Cardinal Health, Inc.
Ear, Nose, Throat · 24d
Cleared May 22, 2009
SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A,...
K091417 · OCY
Terumo Corp.
Gastroenterology & Urology · 9d
Cleared May 21, 2009
OSTEOCRETE BONE VOID FILLER
K071004 · MQV
Bone Solutions, Inc.
Orthopedic · 773d
Cleared May 21, 2009
PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M
K082817 · FLE
Primus Sterilizer Company, LLC
General Hospital · 238d
Cleared May 21, 2009
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
K083391 · JZO
Diagnostic Hybrids, Inc.
Immunology · 185d
Cleared May 21, 2009
INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100
K083751 · CAW
Invacare Corporation
Anesthesiology · 155d
Cleared May 21, 2009
ORALUBE
K090457 · ONK
Pulpdent Corporation
Dental · 87d
Cleared May 21, 2009
SYNTHES SYNAPSE TRANSCONNECTOR
K090549 · KWP
Synthes Spine
Orthopedic · 80d
Cleared May 21, 2009
PERCUTANEOUS DISCECTOMY SYSTEM
K090815 · HRX
Laurimed, LLC
Orthopedic · 57d
Cleared May 21, 2009
METAMORPHOSIS
K091023 · EBF
Kerr Corporation
Dental · 41d
Cleared May 20, 2009
FUSION MEDICAL STI
K081755 · HWC
John Riccio
Orthopedic · 334d
Cleared May 20, 2009
EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS
K083850 · MOB
Euroimmun Us, Inc.
Immunology · 147d
Cleared May 20, 2009
SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
K083921 · HQD
Synergeyes, Inc.
Ophthalmic · 140d
Cleared May 20, 2009
ZELTIQ SYSTEM
K090094 · GEX
Zeltiq Aesthetics
General & Plastic Surgery · 126d
Cleared May 20, 2009
SUPRATHEL WOUND AND BURN DRESSING
K090160 · QSZ
Polymedics Innovations, GmbH
General & Plastic Surgery · 118d
Cleared May 20, 2009
BABI*PLUS BUBBLE PAP VALVE
K090317 · BYE
A Plus Medical
Anesthesiology · 100d
Cleared May 20, 2009
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
K090356 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 97d
Cleared May 20, 2009
HINGE PEDIATRIC PLATING SYSTEM
K090440 · HRS
Pega Medical, Inc.
Orthopedic · 89d
Cleared May 20, 2009
SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01
K090530 · MBI
Ross Creek Medical, Inc.
Orthopedic · 82d
Cleared May 20, 2009
OCULUS MICROCYN WOUND GEL
K090725 · FRO
Oculus Innovative Sciences, Inc.
General & Plastic Surgery · 62d
Cleared May 20, 2009
POWER INFUSER, MODEL M100B-3A
K090736 · FRN
ZOLL Medical Corporation
General Hospital · 62d