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
77617–77640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 2002
NLITE SYSTEM
K014130 · GEX
Icn Photonics , Ltd.
General & Plastic Surgery · 22d
Cleared Jan 07, 2002
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS,...
K011537 · KDI
Dynamic Technology Corp.
Gastroenterology & Urology · 234d
Cleared Jan 07, 2002
PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP
K012275 · HGX
Limerick, Inc.
Obstetrics & Gynecology · 172d
Cleared Jan 07, 2002
INCARE INTERMITTENT CATHETER
K013345 · KOD
Hollister, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 07, 2002
SHARGHP A.V. FISTULA NEEDLE SET
K013384 · FIE
Shargh Pharmaceutical Co., Inc.
Gastroenterology & Urology · 87d
Cleared Jan 07, 2002
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
K013523 · LHI
Shire Biologics, Inc.
General Hospital · 76d
Cleared Jan 07, 2002
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
K014007 · FGE
Guidant Corp.
Gastroenterology & Urology · 33d
Cleared Jan 07, 2002
NYCOCARD CRP CONTROL
K014084 · DCK
Primus Corp.
Immunology · 27d
Cleared Jan 07, 2002
M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
K014191 · IYN
Philips Medical Systems
Radiology · 17d
Cleared Jan 04, 2002
PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE...
K013174 · EZL
Porges S.A.
Gastroenterology & Urology · 102d
Cleared Jan 04, 2002
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
K014037 · KRH
St. Jude Medical, Inc.
Cardiovascular · 28d
Cleared Jan 03, 2002
NEOLEAD
K011564 · DRX
Neotech Products, Inc.
Cardiovascular · 227d
Cleared Jan 03, 2002
3420 DIGIT PULSE OXIMETER, MODEL 3420
K013171 · DQA
Bci, Inc.
Anesthesiology · 101d
Cleared Jan 03, 2002
MODIFICATION TO: POCKETVIEW ECG SOFTWARE
K013311 · MHX
Micromedical Industries, Ltd.
Cardiovascular · 91d
Cleared Jan 03, 2002
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
K013319 · DQA
Nonin Medical, Inc.
Anesthesiology · 90d
Cleared Jan 03, 2002
YELLOW SPECIAL
K013506 · EJT
Metalor Technologies USA
Dental · 73d
Cleared Jan 03, 2002
NUMED MULLINS PTA CATHETER
K013601 · DQY
NuMED, Inc.
Cardiovascular · 64d
Cleared Jan 03, 2002
TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS
K014182 · ITX
Tetrad Corp.
Radiology · 14d
Cleared Jan 02, 2002
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
K003689 · IXK
Canon USA, Inc.
Radiology · 398d
Cleared Jan 02, 2002
BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER
K013304 · DBY
Becton Dickinson Infusion Therapy...
Immunology · 90d
Cleared Jan 02, 2002
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K013514 · MOS
Mri Devices Corp.
Radiology · 72d
Cleared Dec 31, 2001
MSI BIPOLAR SHEATH
K011202 · HRX
Medical Scientific, Inc.
Orthopedic · 256d
Cleared Dec 31, 2001
REMEDY MODEL 2Z12
K012029 · KMG
Apollo Corp.
General Hospital · 186d
Cleared Dec 31, 2001
AUROPAL, ORDER-NO.: 2101
K012839 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 130d