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
88249–88272 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 1998
PHILIPS DUO DIAGNOST
K983069 · OWB
Philips Medical Systems North...
Radiology · 61d
Cleared Nov 02, 1998
POS-T-VAC (AVP-1000)
K983245 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 47d
Cleared Nov 02, 1998
POS-T-VAC (IVP-600)
K983246 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 47d
Cleared Nov 02, 1998
BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER
K983619 · FLL
Barchens Co.
General Hospital · 18d
Cleared Oct 30, 1998
AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
K973985 · BSZ
Datex-Engstrom, Inc.
Anesthesiology · 375d
Cleared Oct 30, 1998
SILENT NIGHT II
K981034 · MNR
Sleep Solutions, Inc.
Anesthesiology · 225d
Cleared Oct 30, 1998
STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX...
K981366 · BTY
Sensor Medics Corp.
Anesthesiology · 198d
Cleared Oct 30, 1998
LTV 1000 VENTILATOR
K981371 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 197d
Cleared Oct 30, 1998
PASTE OPAQUE EX-3
K982766 · EIH
Noritake Co., Inc.
Dental · 85d
Cleared Oct 30, 1998
FINE-JECT
K983067 · FMI
Henke Sass Wolf of America, Inc.
General Hospital · 58d
Cleared Oct 30, 1998
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION...
K983122 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 52d
Cleared Oct 30, 1998
MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY...
K983124 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 52d
Cleared Oct 30, 1998
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K983207 · LYZ
Shijiazhuang Great Eagle Plastic...
General Hospital · 46d
Cleared Oct 29, 1998
SEMPERMED SURGEONS' GLOVES - SUPREME
K981096 · KGO
Semperit Technische Produkte Gesellshaft
General Hospital · 218d
Cleared Oct 29, 1998
STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS
K981497 · FRC
Steritec Products Mfg Co, Inc.
General Hospital · 185d
Cleared Oct 29, 1998
VECTORVISION SPINE MODULE
K981508 · HAW
Brainlab AG
Neurology · 185d
Cleared Oct 29, 1998
NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K982131 · LZA
Ansell Edmont Industrial, Inc.
General Hospital · 134d
Cleared Oct 29, 1998
JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM
K982673 · HIS
Key West Fragrance & Cosmetic
Obstetrics & Gynecology · 90d
Cleared Oct 29, 1998
AIRWATCH II ZONELESS
K982675 · BZH
Enact Health Management Systems
Anesthesiology · 90d
Cleared Oct 29, 1998
AIRWATCH II ZONE
K982676 · BZH
Enact Health Management Systems
Anesthesiology · 90d
Cleared Oct 29, 1998
MEDICAL AIR COMPRESSOR, MODEL # 8413419
K982789 · BTI
Drager, Inc.
Anesthesiology · 80d
Cleared Oct 29, 1998
X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID
K982824 · KPR
I.E.D., Inc.
Radiology · 79d
Cleared Oct 29, 1998
RESTGRID PACKAGE/GYROSCAN NT
K982834 · LNH
Philips Medical Systems North...
Radiology · 78d
Cleared Oct 29, 1998
ELECTRODE SWITCHBOX, MODEL 11-081002
K982835 · DRF
Cardima, Inc.
Cardiovascular · 78d