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
65857–65880 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 2005
ULTRASONIC BIO-MICROSCOPE, MODEL P60
K050980 · IYO
Paradigm Medical Industries, Inc.
Radiology · 37d
Cleared May 26, 2005
MMS VIDEO OPTION
K050993 · LLZ
Medical Measurement Systems B.V.
Radiology · 37d
Cleared May 26, 2005
ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
K051060 · DQY
AngioDynamics, Inc.
Cardiovascular · 30d
Cleared May 26, 2005
ZIEHM QUANTUM
K051064 · OWB
Ziehm Imaging, Inc.
Radiology · 30d
Cleared May 26, 2005
RAYCELL X-RAY BLOOD IRRADIATOR
K051065 · MOT
Mds Nordion
Radiology · 30d
Cleared May 26, 2005
E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL FLAT PANEL DISPLAY
K051201 · LLZ
Barcoview
Radiology · 15d
Cleared May 25, 2005
FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER...
K043149 · LZA
Firstline, LLC
General Hospital · 191d
Cleared May 25, 2005
LIGHT DRAPE
K043234 · MMP
Wrapped IN Comfort
General Hospital · 184d
Cleared May 25, 2005
ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE
K043249 · FMI
Atrion Medical Products, Inc.
General Hospital · 183d
Cleared May 25, 2005
ELECTRODE
K050248 · DRX
Electramold
Cardiovascular · 111d
Cleared May 25, 2005
ULTRA-SOFT SV BALLOON DILATATION CATHETER
K050389 · DQY
Boston Scientific Corp
Cardiovascular · 99d
Cleared May 25, 2005
SALUTE FIXATION SYSTEM
K050610 · GDW
Davol Inc., Sub. C. R. Bard, Inc.
General & Plastic Surgery · 76d
Cleared May 25, 2005
SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX
K050898 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 44d
Cleared May 25, 2005
CPAP HUMIDIFIER, MODEL HC238JHU
K050904 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 44d
Cleared May 25, 2005
DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX,...
K051092 · CCL
Ge Healthcare
Anesthesiology · 27d
Cleared May 25, 2005
BLUELEX
K051203 · EBZ
Monitex Industrial Co., Ltd.
Dental · 14d
Cleared May 24, 2005
NAVIPRO SHOULDER SOFTWARE MODULE
K050897 · HAW
Kinamed, Inc.
Neurology · 46d
Cleared May 24, 2005
BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML)
K050982 · LON
Becton, Dickinson & CO
Microbiology · 35d
Cleared May 24, 2005
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
K051040 · JOX
Medtronic Perfusion Systems
Hematology · 29d
Cleared May 23, 2005
REPROCESSED ENDOSCOPIC TROCAR
K043592 · NLM
Sterilmed, Inc.
Gastroenterology & Urology · 145d
Cleared May 23, 2005
DDAT OMT
K050098 · GWN
Ddat(Uk), Ltd.
Neurology · 125d
Cleared May 23, 2005
ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM,...
K050305 · LCX
Bioscreen Medical, Inc.
Chemistry · 104d
Cleared May 23, 2005
FT2000 SEQUENCER FOR MUSCLE STIMULATOR
K050595 · IPF
Midwest Development
Physical Medicine · 76d
Cleared May 23, 2005
MC6A
K050735 · EKZ
Macan Engineering Co.
Dental · 63d