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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
53233–53256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2009
MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
K090037 · DSI
Medicalgorithmics SP Z.O.O.
Cardiovascular · 136d
Cleared May 22, 2009
CAAS MR FLOW 1.0
K090155 · LLZ
Pie Medical Imaging BV
Radiology · 120d
Cleared May 22, 2009
BIOPRO FEMORAL HEADS
K090208 · JDI
Biopro, Inc.
Orthopedic · 114d
Cleared May 22, 2009
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC...
K090330 · JFY
Siemens Healthcare Diagnostics, Inc.
Chemistry · 101d
Cleared May 22, 2009
FREEHAND
K090340 · GCJ
Prosurgics Limited
General & Plastic Surgery · 101d
Cleared May 22, 2009
NEOSS IMPLANT SYSTEM 03.25
K090452 · DZE
Neoss, Ltd.
Dental · 88d
Cleared May 22, 2009
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
K090461 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 88d
Cleared May 22, 2009
CARESTREAM DRYVIEW 5850 LASER IMAGER
K090469 · LMC
Carestream Health, Inc.
Radiology · 88d
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