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
54697–54720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 2008
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K083213 · HRS
Synthes (Usa)
Orthopedic · 60d
Cleared Dec 30, 2008
CARESTREAM PACS, MODEL CARESTREAM PACS VII
K083673 · LLZ
Carestream Health, Inc.
Radiology · 19d
Cleared Dec 30, 2008
MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL
K083765 · FPA
Medegen Medical Manufacturing Services
General Hospital · 12d
Cleared Dec 29, 2008
LAPEX BCS
K081962 · ILY
Meridian Co., Ltd.
Physical Medicine · 173d
Cleared Dec 29, 2008
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
K082010 · HBF
Stryker Ireland Ltd., Instruments...
Neurology · 167d
Cleared Dec 29, 2008
VICOR PD2I ANALYZER, VERSION 2.1
K082709 · DPS
Vicor Technologies, Inc.
Cardiovascular · 104d
Cleared Dec 29, 2008
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS
K082792 · JDI
Medacta International S.A.
Orthopedic · 97d
Cleared Dec 29, 2008
REJUVENATE MONOLITHIC HIP SYSTEM
K082892 · MEH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 29, 2008
MORTARA ELI 350 ELECTROCARDIOGRAPH
K082946 · DPS
Mortara Instrument, Inc.
Cardiovascular · 88d
Cleared Dec 29, 2008
CLYDESDALE SPINAL SYSTEM
K083026 · MAX
Medtronic Sofamor Danek
Orthopedic · 80d
Cleared Dec 29, 2008
EVITE XL
K083050 · CBK
Draeger Medical AG & Co. KG
Anesthesiology · 76d
Cleared Dec 29, 2008
CORFLO ANTI IV ENTERAL FEEDING TUBE
K083210 · FPD
Corpak Medsystems
Gastroenterology & Urology · 59d
Cleared Dec 29, 2008
WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
K083355 · FRO
Blairex Laboratories, Inc.
General & Plastic Surgery · 46d
Cleared Dec 29, 2008
FRESENIUS STERILE STAY SAFE CAP
K083542 · KDJ
Fresenius Medical Care North America
Gastroenterology & Urology · 31d
Cleared Dec 29, 2008
IKOENGELO, VERSION 2
K083591 · KPQ
Ikoetech, LLC
Radiology · 25d
Cleared Dec 24, 2008
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5
K081060 · GAQ
Core Essence Orthopaedics, LLC
General & Plastic Surgery · 254d
Cleared Dec 24, 2008
TWIN NEUROTRAC-III
K081551 · OMA
Astro-Med, Inc.
Neurology · 204d
Cleared Dec 24, 2008
ENVISION BLOOD GLUCOSE TEST SYSTEM
K082020 · NBW
Infopia Co, Ltd.
Chemistry · 161d
Cleared Dec 24, 2008
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
K083091 · KRD
Biocompatibles UK Limited
Cardiovascular · 68d
Cleared Dec 24, 2008
MODIFICATION TO:MICROFUSE BONE VOID FILLER
K083232 · MQV
Globus Medical, Inc.
Orthopedic · 51d
Cleared Dec 24, 2008
BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001...
K083271 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 48d
Cleared Dec 24, 2008
IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
K083347 · DRL
Fluke Biomedical
Cardiovascular · 41d
Cleared Dec 24, 2008
BD BACTEC Plus Aerobic/F Culture Vials
K083572 · MDB
Becton, Dickinson & CO
Microbiology · 21d
Cleared Dec 24, 2008
CONQUEST PTA BALLOON DILATATION CATHETER
K083657 · DQY
C.R. Bard, Inc.
Cardiovascular · 14d