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
82777–82800 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 2000
EVERSHEARS BIPOLAR SCISSORS
K000496 · GEI
Everest Medical Corp.
General & Plastic Surgery · 69d
Cleared Apr 24, 2000
MEDVIZER PACS, MODEL RELEASE 2000
K000557 · LLZ
Vitel Net
Radiology · 66d
Cleared Apr 24, 2000
ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE
K000612 · KNW
Inrad
Gastroenterology & Urology · 61d
Cleared Apr 24, 2000
MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM...
K000985 · LYY
Matang Mfg. Sdn. Bhd.
General Hospital · 28d
Cleared Apr 24, 2000
GE LOGIQ 700
K001016 · ITX
GE Medical Systems
Radiology · 26d
Cleared Apr 24, 2000
MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
K001105 · KWP
Depuyacromed
Orthopedic · 19d
Cleared Apr 24, 2000
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
K001133 · KHS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 14d
Cleared Apr 24, 2000
LORAD LT-100 LASER TREATMENT SYSTEM
K992597 · GEX
Focus Medical, LLC
General & Plastic Surgery · 265d
Cleared Apr 21, 2000
KSEA CHARDONNES MORCELLATION KNIFE
K000212 · KOH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 88d
Cleared Apr 21, 2000
MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM
K000444 · HIB
Prism Enterprises, Inc.
Obstetrics & Gynecology · 71d
Cleared Apr 21, 2000
CAVERMAP SURGICAL AID
K000507 · ETN
Uromed Corp.
Ear, Nose, Throat · 66d
Cleared Apr 21, 2000
POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR...
K000867 · LYY
Sgmp Co., Ltd.
General Hospital · 35d
Cleared Apr 21, 2000
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
K000956 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 28d
Cleared Apr 21, 2000
KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111
K001123 · MML
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 14d
Cleared Apr 21, 2000
3D MANUAL COARSE MANIPULATOR MN-188NE
K001130 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 11d
Cleared Apr 21, 2000
3D HDRAULIC FINE MICROMANIPULATOR MO-188NE
K001131 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 11d
Cleared Apr 21, 2000
MODIFICATION TO CONVERTORS SURGICAL GOWNS
K001189 · FYA
Allegiance Healthcare Corp.
General Hospital · 9d
Cleared Apr 21, 2000
DEVILBISS NEBULIZER MODEL 800
K993492 · CAF
Sunrise Medical Hhg, Inc.
Anesthesiology · 189d
Cleared Apr 21, 2000
BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP
K993871 · FRG
Allegiance Healthcare Corp.
General Hospital · 158d
Cleared Apr 20, 2000
CRANIAL DRILL
K000195 · HBB
Image-Guided Neurologics, Inc.
Neurology · 90d
Cleared Apr 20, 2000
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
K000247 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 84d
Cleared Apr 20, 2000
PACSSTATION
K000448 · LLZ
Fernandez Industries, Inc.
Radiology · 70d
Cleared Apr 20, 2000
OPART, MODEL MRT-600
K000549 · MOS
Toshiba America Mri, Inc.
Radiology · 62d
Cleared Apr 20, 2000
BETEL POWDER FREE LATEX EXAM GLOVES
K000650 · LYY
Betel Care Sdn. Bhd.
General Hospital · 52d