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
55105–55128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2008
EZLASE 10W
K083069 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 29d
Cleared Nov 12, 2008
SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
K080503 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 261d
Cleared Nov 12, 2008
BENACEL, MODELS C-001, C-002 AND C-005
K080532 · QSY
Unicare Biomedical, Inc.
General & Plastic Surgery · 260d
Cleared Nov 12, 2008
RHAPSODY CT
K081889 · LJT
Grantadler Corporation
General Hospital · 133d
Cleared Nov 12, 2008
AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE
K082762 · JCX
Aardvark Medical
General & Plastic Surgery · 51d
Cleared Nov 12, 2008
DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B
K082763 · MZU
Diazyme Laboratories
Chemistry · 51d
Cleared Nov 12, 2008
D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015
K083190 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 14d
Cleared Nov 10, 2008
TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC
K080771 · GXI
Top Corp.
Neurology · 236d
Cleared Nov 10, 2008
NEXUS I.V. FLUID TRANSFER DEVICE
K080976 · LHI
Nexus Medical, LLC
General Hospital · 217d
Cleared Nov 10, 2008
LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
K081687 · MYF
DiaSorin, Inc.
Microbiology · 146d
Cleared Nov 10, 2008
CLUE MEDICAL AND CLUE MEDICAL BASIC
K082013 · DPS
Telovital GmbH Telemedizin
Cardiovascular · 118d
Cleared Nov 10, 2008
HOLLYWOOD, PACIFICA, REDONDO, VENTURA
K082310 · MAX
Seaspine, Inc.
Orthopedic · 89d
Cleared Nov 10, 2008
SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
K082335 · JEY
Synthes (Usa)
Dental · 88d
Cleared Nov 10, 2008
VENOUS BUBBLE TRAP, MODEL VBT 160
K082412 · DTP
Mapquet Cardiopulmonary AG
Cardiovascular · 81d
Cleared Nov 10, 2008
MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES...
K082457 · LZA
Ansell Healthcare Products, Inc.
General Hospital · 76d
Cleared Nov 10, 2008
PROGENIX
K082463 · NUN
Medtronic Sofamor Danek
Dental · 75d
Cleared Nov 10, 2008
COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS)
K082606 · MUJ
D3 Radiation Planning
Radiology · 63d
Cleared Nov 10, 2008
SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES
K082624 · HRS
Synthes (Usa)
Orthopedic · 62d
Cleared Nov 10, 2008
FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL
K082641 · DQA
Contec Medical System Co., Ltd.
Anesthesiology · 60d
Cleared Nov 10, 2008
BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY
K082876 · GEX
Sharplight Technologies, Ltd.
General & Plastic Surgery · 42d
Cleared Nov 07, 2008
AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25,...
K081011 · HWC
Arex USA
Orthopedic · 212d
Cleared Nov 07, 2008
AIRSONNETT AIRSHOWER AIR 3
K081062 · FRF
Airsonett, Inc.
General Hospital · 207d
Cleared Nov 07, 2008
MOLAR IMPLANT
K081128 · DZE
Nobel Biocare AB
Dental · 200d
Cleared Nov 07, 2008
VANISHPOINT I.V. CATHETER
K081420 · FOZ
Retractable Technologies, Inc.
General Hospital · 171d