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
81145–81168 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2000
BROOKER FEMORAL NAILS
K002278 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 89d
Cleared Oct 23, 2000
THERMAL CAUTERY UNIT, MODEL 150
K002341 · HQO
Geiger Medical Technologies, Inc.
Ophthalmic · 83d
Cleared Oct 23, 2000
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR...
K002389 · GXI
Baylis Medical Co., Inc.
Neurology · 80d
Cleared Oct 23, 2000
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
K002446 · KXK
Sun Nuclear Corp.
Radiology · 75d
Cleared Oct 23, 2000
X-POSURE SYSTEM VERSION 2 RAD
K002500 · KGI
Pronosco A/S
Radiology · 70d
Cleared Oct 23, 2000
REUSABLE CANNULA
K002542 · GCJ
Genicon, LC
General & Plastic Surgery · 68d
Cleared Oct 23, 2000
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K002589 · LPN
Alcon Universal, Ltd.
Ophthalmic · 63d
Cleared Oct 23, 2000
BIOSLEEP
K002622 · OLZ
Oxford Biosignals Limited
Neurology · 61d
Cleared Oct 23, 2000
ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
K002631 · OLX
Eemagine Medical Imaging Solutions GmbH
Neurology · 61d
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