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
65401–65424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2005
MARROW PLUS (M+)
K051695 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 26d
Cleared Jul 19, 2005
THERMAGE THERMACOOL COUPLING FLUID
K051710 · GEI
Thermage, Inc.
General & Plastic Surgery · 22d
Cleared Jul 19, 2005
ACUMEN IMAGE GUIDED SURGICAL SYSTEM
K051724 · HAW
Ebi, L.P.
Neurology · 22d
Cleared Jul 19, 2005
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY
K051735 · HRS
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Jul 19, 2005
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
K051737 · LZO
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 19, 2005
SECUR-FIT MAX AND PLUS MAX HIP STEMS
K051738 · LZO
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 18, 2005
CODMAN VPV SYSTEM, MODEL 82-3192
K050739 · JXG
Codman & Shurtleff, Inc.
Neurology · 119d
Cleared Jul 18, 2005
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
K051316 · LJE
C.R. Bard, Inc.
Gastroenterology & Urology · 59d
Cleared Jul 18, 2005
EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC)
K051430 · LPL
Hydrogel Vision Corporation
Ophthalmic · 47d
Cleared Jul 18, 2005
VITESSE 2.0
K051497 · MUJ
Varian Medical Systems, Inc.
Radiology · 42d
Cleared Jul 18, 2005
L.E. DEMETRON II
K051545 · EBZ
Kerr Corporation (Danbury)
Dental · 38d
Cleared Jul 18, 2005
XELERIS 2 PROCESSING AND REVIEW WORKSTATION
K051673 · LLZ
GE Medical Systems
Radiology · 25d
Cleared Jul 15, 2005
VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
K043406 · NDN
Depuy Spine, Inc.
Orthopedic · 217d
Cleared Jul 15, 2005
BIORESORB MACRO PORE
K050260 · LYC
Oraltronics Dental Implant Technology...
Dental · 162d
Cleared Jul 15, 2005
AMSINO ENDOTRACHEAL TUBE
K050785 · BTR
Amsino International, Inc.
Anesthesiology · 109d
Cleared Jul 15, 2005
THE ODFS DROPPED FOOT STIMULATOR
K050991 · GZI
Department of Medical Physics and...
Neurology · 87d
Cleared Jul 15, 2005
VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST
K051062 · DQX
Flowcardia, Inc.
Cardiovascular · 80d
Cleared Jul 15, 2005
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE...
K051253 · MEA
Baxter Healthcare Corp
General Hospital · 60d
Cleared Jul 15, 2005
RES TRAXX DATA CENTER
K051314 · BZD
Resmed, Ltd.
Anesthesiology · 56d
Cleared Jul 15, 2005
ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
K051381 · LYC
Ace Surgical Supply Co., Inc.
Dental · 49d
Cleared Jul 15, 2005
HYDROGUM 5
K051424 · ELW
Zhermack S.P.A.
Dental · 44d
Cleared Jul 15, 2005
LNOP BLUE OXIMETRY SENSOR
K051439 · DQA
Masimo Corporation
Anesthesiology · 43d
Cleared Jul 15, 2005
DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES
K051635 · KOI
Ge Healthcare
Anesthesiology · 25d
Cleared Jul 15, 2005
ECLIPSE BONDING AGENT
K051707 · KLE
Dentsply Intl.
Dental · 18d