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
88297–88320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 1998
AESCULAP HILAN MOTOR SYSTEM
K980686 · HBB
Aesculap, Inc.
Neurology · 191d
Cleared Sep 02, 1998
PIV SYSTEM
K981032 · LDQ
Medical Solutions, Inc.
General & Plastic Surgery · 167d
Cleared Sep 02, 1998
ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX...
K981970 · ELW
Cavex Holland BV
Dental · 90d
Cleared Sep 02, 1998
ACCU-CHEK COMFORT CURVE TEST STRIP
K982002 · LFR
Boehringer Mannheim Corp.
Chemistry · 86d
Cleared Sep 02, 1998
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
K982005 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 86d
Cleared Sep 02, 1998
NUCAMMA R+
K982044 · KPS
Is2 Research, Inc.
Radiology · 84d
Cleared Sep 02, 1998
NUCAMMA RX
K982045 · KPS
Is2 Research, Inc.
Radiology · 84d
Cleared Sep 02, 1998
MODEL MS-2 HANDPIECE
K982050 · EFB
Parkell, Inc.
Dental · 83d
Cleared Sep 02, 1998
VOLUMAX CT IMAGING SYSTEM
K982060 · JAK
Elscint, Inc.
Radiology · 83d
Cleared Sep 02, 1998
TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K982157 · LNH
Field Effects
Radiology · 75d
Cleared Sep 02, 1998
QUANTI-TEST SYSTEM
K982578 · SCL
Panatrex, Inc.
General Hospital · 41d
Cleared Sep 02, 1998
OMNI PRO LATEX SURGICAL GLOVE, POWDERED
K982613 · KGO
Omnigrace (Thailand) , Ltd.
General Hospital · 37d
Cleared Sep 02, 1998
PYRAMID
K982645 · EBF
Bisco, Inc.
Dental · 35d
Cleared Sep 02, 1998
PHILIPS BV300 SERIES RELEASE 2.1
K982706 · OXO
Philips Medical Systems, Inc.
Radiology · 29d
Cleared Sep 02, 1998
SOFT (HYDROPHILIC) CONTACT LENSES
K982774 · LPL
Cl-Tinters
Ophthalmic · 26d
Cleared Sep 01, 1998
SULLIVAN AUTOSET
K980721 · BZD
Resmed, Ltd.
Anesthesiology · 189d
Cleared Sep 01, 1998
PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
K980762 · DTM
Pall Corp.
Cardiovascular · 186d
Cleared Sep 01, 1998
COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND...
K981168 · LPN
Allergan, Inc.
Ophthalmic · 153d
Cleared Sep 01, 1998
COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER
K981952 · GEX
Instruments For Medicine and Diagnostics
General & Plastic Surgery · 90d
Cleared Sep 01, 1998
ESOPHAGEAL STETHOSCOPE
K982193 · BZT
Shore Medical, Inc.
Anesthesiology · 71d
Cleared Sep 01, 1998
VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM
K982345 · JAA
Cardiac Mariners, Inc.
Radiology · 57d
Cleared Sep 01, 1998
ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2...
K982501 · JIX
Alko Diagnostic Corp.
Chemistry · 43d
Cleared Sep 01, 1998
ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC)...
K982904 · LPL
Les Laboratoires Blanchard
Ophthalmic · 14d
Cleared Aug 31, 1998
IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1)
K964977 · LFF
Interactive Living Systems, Inc.
Physical Medicine · 627d