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
102433–102456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1995
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
K951631 · LFM
Bayer Corp.
Chemistry · 63d
Cleared Jun 09, 1995
ACUFEX ENDOBUTTON PACK
K951859 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 49d
Cleared Jun 09, 1995
INSULATED ELECTROSURGICAL INSTRUMENTS
K951986 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 43d
Cleared Jun 08, 1995
W&H 896 TOP LIGH HIGHSPEED
K944709 · EFB
A-Dec, Inc.
Dental · 258d
Cleared Jun 08, 1995
DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME
K946209 · BYD
Med-Plastics Intl., Inc.
Anesthesiology · 169d
Cleared Jun 08, 1995
LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC)
K946257 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 167d
Cleared Jun 08, 1995
SURGICAL INSTRUMENT MOTOTRS AND ACCESSORIES/ATTACHMENTS
K951065 · DZE
Steri-Oss, Inc.
Dental · 92d
Cleared Jun 08, 1995
RUSCH ENDOBRONCHIAL TUBE SETS
K951091 · BTS
Rusch Intl.
Anesthesiology · 91d
Cleared Jun 08, 1995
C-THRU CORONARY GUIDE WIRE
K951109 · DQX
Schneider (Europe) GmbH
Cardiovascular · 90d
Cleared Jun 08, 1995
LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER
K951147 · CCW
Leigh Med Tech, Inc.
Anesthesiology · 87d
Cleared Jun 08, 1995
FIBER HEAD LIGHT FH-300
K951337 · HPQ
Neitz Instruments Company, Ltd.
Ophthalmic · 76d
Cleared Jun 08, 1995
INCASE EXTENSIBLE BAG--NON-STERILE
K951420 · LYU
Alpha Surgical, Inc.
General Hospital · 73d
Cleared Jun 08, 1995
DEGUBOND 4
K951787 · EJT
Degussa Corp.
Dental · 52d
Cleared Jun 08, 1995
ADHEROL SEPP APPLICATOR
K952007 · FRO
Medi-Flex Hospital Products, Inc.
General & Plastic Surgery · 41d
Cleared Jun 08, 1995
FLEXLIFE
K952036 · BYD
Mallinckrodt Medical
Anesthesiology · 38d
Cleared Jun 08, 1995
PFT FILTER
K952062 · CAH
Intertech Resources, Inc.
General Hospital · 37d
Cleared Jun 08, 1995
SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC
K952169 · BTM
Intertech Resources, Inc.
Anesthesiology · 31d
Cleared Jun 08, 1995
KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES
K952192 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 30d
Cleared Jun 08, 1995
SIMS INTERTECH HYPERINFLATION BAG SYSTEM
K952214 · NHK
Intertech Resources, Inc.
Anesthesiology · 28d
Cleared Jun 08, 1995
NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS
K952421 · GCJ
American Hydro-Surgical Instruments,...
General & Plastic Surgery · 16d
Cleared Jun 07, 1995
GRASSI GASTROJEJUNOSTOMY TUBE
K932880 · KNT
Bissell Medical Products, Inc.
Gastroenterology & Urology · 723d
Cleared Jun 07, 1995
ORTHOMET HMC FEMORAL STEM COMPONENT
K936310 · LPH
Orthomet, Inc.
Orthopedic · 426d
Cleared Jun 07, 1995
OSTEONICS OMNIFIT AD HIP STEM SERIES
K940715 · LPH
Osteonics Corp.
Orthopedic · 474d
Cleared Jun 07, 1995
NON-MYDRIATIC RETINAL CAMERA
K941234 · HKI
Canon USA, Inc.
Ophthalmic · 449d