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
58033–58056 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 2007
SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
K072578 · HSD
Synthes (Usa)
Orthopedic · 76d
Cleared Nov 28, 2007
IST ANTERIOR CERVICAL PLATE SYSTEM
K072650 · KWQ
Innovative Spinal Technologies, Inc.
Orthopedic · 70d
Cleared Nov 28, 2007
SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES
K072672 · NKB
Abbott Spine, Inc.
Orthopedic · 68d
Cleared Nov 28, 2007
3S HEMI TOE
K072922 · KWD
Trilliant Surgical, Ltd.
Orthopedic · 44d
Cleared Nov 28, 2007
GYN DISPOSABLES TENACULUM 356T
K073182 · HDC
Gyn-Disposables, Inc.
Obstetrics & Gynecology · 15d
Cleared Nov 27, 2007
EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR
K071624 · GZJ
Everlife Medical Equipment Co., Ltd.
Neurology · 166d
Cleared Nov 27, 2007
NUFACE, MODEL NU-4003
K072260 · NFO
Carol Cole Company
Neurology · 105d
Cleared Nov 27, 2007
MODELS EMS 5.0, EMS 5.1
K072795 · IPF
Koalaty Products, Inc.
Physical Medicine · 57d
Cleared Nov 27, 2007
MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER
K073054 · HWC
Cayenne Medical, Inc.
Orthopedic · 28d
Cleared Nov 27, 2007
BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
K073102 · LZO
Biomet Manufacturing Corp
Orthopedic · 25d
Cleared Nov 26, 2007
MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP
K062575 · LAG
Princeton BioMeditech Corp.
Toxicology · 452d
Cleared Nov 26, 2007
PRIMUS A1CARE ASSAY
K062658 · LCP
Primus Corp.
Chemistry · 446d
Cleared Nov 26, 2007
HAMILTON-G5
K070513 · CBK
Hamilton Medical AG
Anesthesiology · 277d
Cleared Nov 26, 2007
DISPENSER DP 20
K071588 · FRN
NOUVAG AG
General Hospital · 168d
Cleared Nov 26, 2007
PRO-PICC, BASIC TRAY
K072509 · LJS
Medcomp
General Hospital · 81d
Cleared Nov 26, 2007
MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR
K072780 · IZW
Ralco S.R.L.
Radiology · 59d
Cleared Nov 26, 2007
FUNHALER, MODEL V-201E
K072822 · CAF
Infamed , Ltd.
Anesthesiology · 55d
Cleared Nov 26, 2007
RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
K072827 · MJE
Remel, Inc.
Microbiology · 54d
Cleared Nov 26, 2007
CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
K072846 · JPK
R&D Systems, Inc.
Hematology · 53d
Cleared Nov 26, 2007
DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
K072921 · MEB
Symbios Medical Products, LLC
General Hospital · 42d
Cleared Nov 21, 2007
FIDELITY 200 CARDIAC EVENT RECORDER
K071228 · DXH
Signalife, Inc.
Cardiovascular · 202d
Cleared Nov 21, 2007
AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
K071406 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 184d
Cleared Nov 21, 2007
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
K071521 · DWC
Terumo Cardiovascular Systems Corp.
Cardiovascular · 170d
Cleared Nov 21, 2007
REVEAL XT
K071641 · DSI
Medtronic, Inc.
Cardiovascular · 159d