FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
87745–87768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 29, 1998
MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC
K982916 · MOS
Medrad, Inc.
Radiology · 71d
Cleared Oct 29, 1998
XCT 2000 L PQCT BONE DENSITOMETER
K983273 · KGI
Medical Systems, Inc.
Radiology · 42d
Cleared Oct 29, 1998
GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM
K983436 · JAQ
Gammamed USA
Radiology · 30d
Cleared Oct 29, 1998
WISE (II) IMAGE MANAGEMENT SYSTEM
K983447 · LMB
Sectra-Imtec AB
Radiology · 29d
Cleared Oct 29, 1998
GENESIS BLS
K983643 · BTL
O-Two Systems Intl., Inc.
Anesthesiology · 13d
Cleared Oct 29, 1998
EMT RESUSCITATOR
K983705 · BTL
O-Two Systems Intl., Inc.
Anesthesiology · 8d
Cleared Oct 29, 1998
AUTOVENT 1000
K983785 · BTL
O-Two Systems Intl., Inc.
Anesthesiology · 2d
Cleared Oct 28, 1998
SPIROCARD
K973138 · BZG
Qrs Diagnostic, LLC
Anesthesiology · 433d
Cleared Oct 28, 1998
MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT
K974581 · DRT
Invivo Research, Inc.
Cardiovascular · 324d