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
122401–122424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 1991
ADJUSTRETTE - DAO, MODIFICATION
K911498 · ESD
Qualitone
Ear, Nose, Throat · 21d
Cleared Apr 19, 1991
ELEGANCE - DEO, MODIFICATION
K911499 · ESD
Qualitone
Ear, Nose, Throat · 21d
Cleared Apr 19, 1991
ULTRA & ULTRA LITE II, MODIFICATION
K911504 · ESD
Qualitone
Ear, Nose, Throat · 16d
Cleared Apr 18, 1991
PATHWAY II ELECTROMYOGRAPH
K897132 · HCC
The Prometheus Group
Neurology · 477d
Cleared Apr 18, 1991
DISCRETE PHOTOMETRIC CHEMISTRY ANALYSER
K904783 · JJQ
Industrial Chemical Measurement
Chemistry · 178d
Cleared Apr 18, 1991
PLANMED SOPHIE
K904953 · IZH
Planmeca USA, Inc.
Radiology · 164d
Cleared Apr 18, 1991
IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES
K905236 · NHJ
Percussionaire Corp.
Anesthesiology · 162d
Cleared Apr 18, 1991
URESIL VALVE CUTTER
K905528 · DWQ
Uresil Corp.
Cardiovascular · 129d
Cleared Apr 18, 1991
LEEP REDIKIT
K910253 · HEE
CooperSurgical, Inc.
Obstetrics & Gynecology · 86d
Cleared Apr 18, 1991
DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)
K910254 · HHE
CooperSurgical, Inc.
Obstetrics & Gynecology · 86d
Cleared Apr 18, 1991
SCHNEIDER MAGNARAIL PROBING CATHETER
K910259 · DQO
Schneider Intl., Ltd.
Cardiovascular · 86d
Cleared Apr 18, 1991
PREMIXED DIALYSATE FOR HEMODIAFILTRATION
K910270 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 85d
Cleared Apr 18, 1991
SYSTEM 7300 PULSE OXIMETER
K910521 · DQA
Advanced Medical Instruments, Inc.
Anesthesiology · 70d
Cleared Apr 18, 1991
MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT
K910630 · DTD
Medtronic Vascular
Cardiovascular · 64d
Cleared Apr 18, 1991
ENDOPATH VERESS NEEDLE
K910855 · FHP
Symbiosis Corp.
Gastroenterology & Urology · 49d
Cleared Apr 18, 1991
VARIOUS TEMPLATE APPLICATORS
K910862 · IWJ
Best Industries
Radiology · 48d
Cleared Apr 18, 1991
MODEL 5857-3M LEAD END CAP KIT
K911048 · DTD
Medtronic Vascular
Cardiovascular · 41d
Cleared Apr 18, 1991
TAN CHONG GLOVE, HYPOALLERGENIC
K911146 · LYY
Boston Medical Corp.
General Hospital · 42d
Cleared Apr 18, 1991
INTIMAX(TM) IRRIGATION CATHETER
K911181 · GCA
Applied Vascular Devices, Inc.
Gastroenterology & Urology · 31d
Cleared Apr 18, 1991
ANTIMICROBIAL AMIKACIN
K911303 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 24d
Cleared Apr 18, 1991
SOPHYCAMERA DSX BODYTRAK
K911346 · IYX
Sopha Medical Systems, Inc.
Radiology · 22d
Cleared Apr 17, 1991
ALLERGEN MODULES FOR ALASTAT TM
K894227 · DHB
Diagnostic Products Corp.
Immunology · 667d
Cleared Apr 17, 1991
THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER
K900197 · EWO
Sound Linked Data, Inc.
Ear, Nose, Throat · 456d
Cleared Apr 17, 1991
CATHETER, NASAL, OXYGEN
K902420 · CAT
Gainor Medical Europe, Ltd.
Anesthesiology · 321d