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
80641–80664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2000
NEUROMAP WITH NEURO 100
K002773 · GWF
Radionics, Inc.
Neurology · 47d
Cleared Oct 23, 2000
KSEA NEURO-FIBERSCOPE
K002788 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 46d
Cleared Oct 23, 2000
WHEELCHAIR, MECHANICAL SERIES MODEL 3100
K002943 · IOR
Mada Medical Products, Inc.
Physical Medicine · 32d
Cleared Oct 23, 2000
MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM
K002980 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Oct 23, 2000
AERO-CLICK
K993094 · BZD
Map Medizintechnik Fur Arzt Und...
Anesthesiology · 403d
Cleared Oct 20, 2000
RADIOCAMERAS EXTRACRANIAL SYSTEM
K000246 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 267d
Cleared Oct 20, 2000
DA VINCHI EEG AND EMG/EP SYSTEMS
K000963 · GWF
Airsep Corp.
Neurology · 210d
Cleared Oct 20, 2000
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
K001646 · CBK
Puritan Bennett Corp.
Anesthesiology · 143d
Cleared Oct 20, 2000
WACKERS-LIU CQ SOFTWARE
K002229 · KPS
Eclipse Systems, Inc.
Radiology · 88d
Cleared Oct 20, 2000
LACTOSORB PUSH SCREW
K002423 · DZL
Biomet, Inc.
Dental · 73d
Cleared Oct 20, 2000
STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
K002547 · HQP
Starion Instruments
Ophthalmic · 64d
Cleared Oct 20, 2000
DURAGARD SODIUM FLUORIDE VARNISH
K002581 · LBH
Sultan Dental Products, Ltd.
Dental · 63d
Cleared Oct 20, 2000
DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K002814 · LYZ
Shanghai PM Plastics Enterise Co., Ltd.
General Hospital · 39d
Cleared Oct 20, 2000
NICHOLS ADVANTAGE THYROGLOB
K002888 · MSW
Nichols Institute Diagnostics
Immunology · 35d
Cleared Oct 20, 2000
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC
K002949 · DSP
Datascope Corp.
Cardiovascular · 29d
Cleared Oct 20, 2000
BACT/ALERT CSR
K003104 · LJF
Organon Teknika Corp.
Microbiology · 52d
Cleared Oct 20, 2000
MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS
K003121 · IYO
Medison America, Inc.
Radiology · 15d
Cleared Oct 20, 2000
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K003125 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Oct 20, 2000
VISIJET HYDROKERATOME, MODEL 50
K991124 · MYD
Visijet, Inc.
Ophthalmic · 567d
Cleared Oct 20, 2000
BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/...
K994276 · LZA
Biopro (M) Sdn Bhd
General Hospital · 305d
Cleared Oct 20, 2000
BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN,...
K994281 · LZA
Biopro (M) Sdn Bhd
General Hospital · 305d
Cleared Oct 20, 2000
CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES
K994320 · NCZ
Cantor & Silver , Ltd.
Ophthalmic · 303d
Cleared Oct 19, 2000
0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE
K000632 · FOZ
Avitro, LLC
General Hospital · 238d
Cleared Oct 19, 2000
MACROPOREMX MANDIBULAR FIXATION SYSTEM
K000696 · JEY
Macropore Biosurgery, Inc.
Dental · 232d