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
82273–82296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 20, 2000
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
K000868 · LZA
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Apr 20, 2000
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
K000875 · JJY
Bio-Rad
Chemistry · 31d
Cleared Apr 20, 2000
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K000953 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 27d
Cleared Apr 20, 2000
PICO SMOKERLYZER, MODEL EC-50
K000962 · CCJ
Bedfont Scientific, Ltd.
Chemistry · 27d
Cleared Apr 20, 2000
PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
K001102 · FPA
Rd Medical Mfg., Inc.
General Hospital · 15d
Cleared Apr 20, 2000
STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
K992732 · FOZ
Dumex Medical Surgical Products, Ltd.
General Hospital · 251d
Cleared Apr 20, 2000
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
K993356 · GKZ
Coulter Corp.
Hematology · 197d
Cleared Apr 20, 2000
FRIALIT-2 MH-2 ABUTMENT
K994174 · DZE
Friadent GmbH
Dental · 132d
Cleared Apr 19, 2000
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
K000205 · MQE
Rocket Medical Plc
Obstetrics & Gynecology · 89d