FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
123457–123480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 1991
CONDOM SEAL
K903715 · EXJ
Mark Sullivan, M.D., P.C.
Gastroenterology & Urology · 162d
Cleared Jan 23, 1991
ST-E1 OVERTUBE
K903842 · FED
Olympus Corp.
Gastroenterology & Urology · 155d
Cleared Jan 23, 1991
SEROZYME CORTISOL TEST KIT
K903975 · CGR
Serono-Baker Diagnostics, Inc.
Chemistry · 148d
Cleared Jan 23, 1991
JMB TRADING COMPANY SUNGLASSES
K904161 · HQY
Jmb Trading Co.
Ophthalmic · 134d
Cleared Jan 23, 1991
FLUOROSCOPIC TABLE, TILT OR POWER TILTING MED. TAB
K904722
Tri W-G, Inc.
Radiology · 97d
Cleared Jan 23, 1991
CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II
K904989 · JJY
Creative Laboratory Products, Inc.
Chemistry · 77d
Cleared Jan 23, 1991
FLEXIBLE INTRACARDIAC SUCTION DEVICE
K905008 · DTS
Gish Biomedical, Inc.
Cardiovascular · 78d
Cleared Jan 23, 1991
IMX FREE TRIIODOTHYRONINE
K905261 · CDP
Abbott Laboratories
Chemistry · 63d
Cleared Jan 23, 1991
620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB
K905265 · IXR
Tri W-G, Inc.
Radiology · 61d
Cleared Jan 23, 1991
STORZ S6000 LIGHT SOURCE
K905376 · FCW
Storz Instrument Co.
Gastroenterology & Urology · 54d
Cleared Jan 23, 1991
TOPICAL COOLING PAD, MODEL 7000
K905568 · DTR
Daily Medical Products, Inc.
Cardiovascular · 42d
Cleared Jan 23, 1991
FLAGEN TRIIODOTHYRONINE (T3) ASSAY
K905656 · CDP
Cyberfluor, Inc.
Chemistry · 37d
Cleared Jan 23, 1991
GEN-PROBE LUMINOMETER-LEADER 450
K905762 · JJQ
Gen-Probe, Inc.
Chemistry · 27d
Cleared Jan 23, 1991
SURE GRIP, HAND CONTROLS MODEL SG-1
K910072 · IPQ
Howell Ventures , Ltd.
Physical Medicine · 14d
Cleared Jan 23, 1991
ROMFLEX REHAB EQUIP EXTREMITIES UNIT
K910150 · BXB
Dyna Flex, Intl.
Physical Medicine · 9d
Cleared Jan 22, 1991
AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT
K903808 · IZG
Advanced Med/Surg, Inc.
Radiology · 155d
Cleared Jan 22, 1991
VIDEO OTOSCOPE
K904802 · ERA
Jedmed Instrument Co.
Ear, Nose, Throat · 90d
Cleared Jan 22, 1991
STORZ DRAEGER ROTOR KERATOME
K904845 · HNO
Storz Instrument Co.
Ophthalmic · 89d
Cleared Jan 22, 1991
MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS
K905207 · IME
Micro Surgical Instruments Corp.
Physical Medicine · 63d
Cleared Jan 22, 1991
GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION
K905463 · FOZ
Angiosystems, Inc.
General Hospital · 48d
Cleared Jan 18, 1991
MODEL T11 FLUIDOTHERAPY UNIT
K896817 · LSB
Henley Intl.
Physical Medicine · 410d
Cleared Jan 18, 1991
BIFLEX(TM) ANNULOPLASTY RING
K902159 · KRH
St. Jude Medical, Inc.
Cardiovascular · 248d
Cleared Jan 18, 1991
SERIES 1500 RESPONDER
K902782 · LDD
Marquette Electronics, Inc.
Cardiovascular · 206d
Cleared Jan 18, 1991
OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C
K903133 · DXN
Omron Marshall Products, Inc.
Cardiovascular · 185d