FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77017–77040 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 31, 2001
MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE
K013556 · FOZ
Tyco Healthcare
General Hospital · 67d
Cleared Dec 31, 2001
POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING)
K013942 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 32d
Cleared Dec 31, 2001
STRYKER PAINPUMP
K014091 · FRN
Stryker Corp.
General Hospital · 19d
Cleared Dec 28, 2001
MAGNETOM TRIO SYSTEM
K013586 · LNH
Siemens Medical Systems, Inc.
Radiology · 59d
Cleared Dec 28, 2001
SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
K013721 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 49d
Cleared Dec 27, 2001
SPINAL MESH SYSTEM
K011406 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 233d
Cleared Dec 27, 2001
KIMSTIM AURICULAR ELECTRODE
K011691 · GXY
Kim Institute For Rehabilitation...
Neurology · 210d
Cleared Dec 27, 2001
AVALON CUP SYSTEM
K011887 · JDI
Orthopedic Source, Inc.
Orthopedic · 192d