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
93745–93768 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1997
RADIONICS BURR HOLE VALVE
K970578 · JXG
Radionics, Inc.
Neurology · 110d
Cleared Jun 04, 1997
ISG FAMILY OF VIEWING WANDS
K970865 · HAW
I.S.G. Technologies, Inc.
Neurology · 86d
Cleared Jun 04, 1997
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
K970905 · CHI
Beckman Instruments, Inc.
Chemistry · 84d
Cleared Jun 04, 1997
TAMARYN I.V. FLOW REGULATOR EXTENSION SET
K971066 · FPA
Tamaryn Medical Systems, Inc.
General Hospital · 72d
Cleared Jun 04, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971220 · JKA
Greiner America, Inc.
Chemistry · 63d
Cleared Jun 04, 1997
SERIES XE, SERIES SE, SERIES TE
K971350 · EGS
Micro-Mega Societe Anonyme
Dental · 55d
Cleared Jun 04, 1997
DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
K971424 · LYY
Ansell Perry
General Hospital · 47d
Cleared Jun 04, 1997
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS
K971465 · HOY
National Healthcare Mfg. Corp.
General Hospital · 43d
Cleared Jun 04, 1997
DUQIAO
K971551 · HQY
Duqiao Glasses (Group) Co. , Ltd.
Ophthalmic · 37d
Cleared Jun 04, 1997
BENCHMARK-IV
K971575 · EJT
J.F. Jelenko & Co., Inc.
Dental · 58d
Cleared Jun 04, 1997
STERILE SUREFLEX FILES AND INSTRUMENTS
K971603 · EFA
Dentsply Intl.
Dental · 34d
Cleared Jun 03, 1997
ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER
K964549 · ITX
Aloka Co., Ltd.
Radiology · 202d
Cleared Jun 03, 1997
AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT
K965204 · KYI
Avanta Orthopaedics, Inc.
Orthopedic · 159d
Cleared Jun 03, 1997
CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR
K970243 · GEX
Cynosure, Inc.
General & Plastic Surgery · 132d
Cleared Jun 03, 1997
SOLO
K970523 · INI
Ranger All Season Corp.
Physical Medicine · 112d
Cleared Jun 03, 1997
TEMPOCEM NE (MULTIPLE)
K970774 · EMA
Foremost Dental Mfg., Inc.
Dental · 91d
Cleared Jun 03, 1997
TEMPO CEM (MULTIPLE)
K970775 · EMA
Foremost Dental Mfg., Inc.
Dental · 91d
Cleared Jun 03, 1997
INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S...
K970791 · LTZ
Custom Services Intl., Inc.
Obstetrics & Gynecology · 91d
Cleared Jun 03, 1997
TRU-PULSE CO2 SURGICAL LASER
K970804 · GEX
Tissue Technologies, Inc.
General & Plastic Surgery · 91d
Cleared Jun 03, 1997
SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER
K970823 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 89d
Cleared Jun 03, 1997
EASY ROD
K970950 · MNH
Acromed Corp.
Orthopedic · 81d
Cleared Jun 03, 1997
OSTEONICS RESTORATION ACETABULAR RING
K970957 · JDJ
Osteonics Corp.
Orthopedic · 78d
Cleared Jun 03, 1997
ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
K971036 · GCY
Interpore Intl.
General & Plastic Surgery · 75d
Cleared Jun 03, 1997
HEMAGEN ANTI CARDIOLIPIN SCREEN
K971039 · MID
Hemagen Diagnostics, Inc.
Immunology · 74d