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
82705–82728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2000
BIOSCANNER TRIGLYCERIDES TEST STRIPS
K000586 · JGY
Polymer Technology Systems, Inc.
Chemistry · 132d
Cleared Jul 03, 2000
6F & 7F INTRODUCING CATHETERS (MODIFICATION)
K001135 · DYB
Cordis Corp.
Cardiovascular · 84d
Cleared Jul 03, 2000
OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING...
K001235 · MRC
Alcon Universal, Ltd.
Ophthalmic · 77d
Cleared Jul 03, 2000
OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907
K001848 · DXN
Omron Healthcare, Inc.
Cardiovascular · 14d
Cleared Jul 03, 2000
EZ LDL CHOLESTEROL TEST SYSTEM
K993741 · MRR
Sigma Diagnostics, Inc.
Chemistry · 242d
Cleared Jun 30, 2000
FUTURA SAFETY SYRINGE
K000860 · MEG
Sheila W. Pickering
General Hospital · 105d
Cleared Jun 30, 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE...
K000952 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 98d
Cleared Jun 30, 2000
NORMOCARB STERILE BICARBONATE RENAL DIALYSIS
K001059 · KPO
Novex Pharma
Gastroenterology & Urology · 88d
Cleared Jun 30, 2000
MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
K001069 · OLW
Physiometrix, Inc.
Neurology · 88d
Cleared Jun 30, 2000
BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501
K001081 · DSB
Cardiodynamics International Corp.
Cardiovascular · 87d
Cleared Jun 30, 2000
OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED,...
K001095 · CCL
Teledyne Analytical Instruments
Anesthesiology · 87d
Cleared Jun 30, 2000
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
K001101 · GWF
Excel Tech. , Ltd.
Neurology · 86d
Cleared Jun 30, 2000
WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)
K001103 · GWQ
Excel Tech. , Ltd.
Neurology · 86d
Cleared Jun 30, 2000
GENYX FLEXIBLE INJECTION NEEEDLE
K001146 · FBK
Geny Medical, Inc.
Gastroenterology & Urology · 81d
Cleared Jun 30, 2000
PERFORMER 30 HPS
K001322 · GEX
Cornelia Damsky, Inc.
General & Plastic Surgery · 65d
Cleared Jun 30, 2000
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
K001611 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 36d
Cleared Jun 30, 2000
COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT...
K001664 · MHX
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 30, 2000
AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
K001670 · DXN
Omron Healthcare, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2000
ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
K001671 · DXN
Omron Healthcare, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2000
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
K001674 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 29d
Cleared Jun 30, 2000
VSCORE WITH EKG SIGNAL GATING
K001682 · JAK
Vital Images, Inc.
Radiology · 29d
Cleared Jun 30, 2000
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K001688 · DQA
Datex-Ohmeda, Inc.
Anesthesiology · 28d
Cleared Jun 30, 2000
AGILENT COMPONENT MONITORING SYSTEM
K001722 · MHX
Agilent Technologies Deutschland GmbH
Cardiovascular · 24d
Cleared Jun 30, 2000
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
K001776 · MWI
Agilent Technologies, Inc.
Cardiovascular · 30d