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
82537–82560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 2000
DIMENSION GARANT L, DIMENSION GARANT L QUICK
K000588 · ELW
Espe Dental AG
Dental · 37d
Cleared Mar 30, 2000
DIMENSION PENTA H, DIMENSION PENTA H QUICK
K000591 · ELW
Espe Dental AG
Dental · 37d
Cleared Mar 30, 2000
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
K000697 · BZE
Allegiance Healthcare Corp.
Anesthesiology · 29d
Cleared Mar 30, 2000
SMITH & NEPHEW SUTURELOK, MODEL 7207321
K000717 · OCW
Smith & Nephew, Inc.
Gastroenterology & Urology · 27d
Cleared Mar 30, 2000
COLORADO II SPINAL SYSTEM
K984360 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 479d
Cleared Mar 30, 2000
PACIFIC SURGICAL PATTIES
K993019 · HBA
V. Mueller Neuro/Spine
Neurology · 204d
Cleared Mar 30, 2000
OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND...
K993041 · FAJ
The Olympus Optical Co.
Gastroenterology & Urology · 202d
Cleared Mar 30, 2000
MICRINS MICROSURGICAL SUTURE
K993970 · GAR
Micrins Surgical, Inc.
General & Plastic Surgery · 128d
Cleared Mar 29, 2000
SINGLE SIZE TENDON SPACER
K000019 · HXA
Medist International
Orthopedic · 85d
Cleared Mar 29, 2000
ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
K000154 · FWN
E. Benson Hood Lab, Inc.
Ear, Nose, Throat · 70d
Cleared Mar 29, 2000
BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY
K000292 · LLZ
Barco N.V.
Radiology · 58d
Cleared Mar 29, 2000
BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY
K000293 · LLZ
Barco N.V.
Radiology · 58d
Cleared Mar 29, 2000
HARDYDISK, TETRACYCLINE 30MCG
K000304 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Mar 29, 2000
SPIRO PRO
K000648 · BTY
Erich Jaeger GmbH
Anesthesiology · 30d
Cleared Mar 29, 2000
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
K000659 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Mar 29, 2000
POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN...
K000671 · LYY
Sgmp Co., Ltd.
General Hospital · 30d
Cleared Mar 29, 2000
ZUMA GUIDE CATHETERS
K000677 · DQY
Medtronic Vascular
Cardiovascular · 29d
Cleared Mar 29, 2000
SYNTHES ANTERIOR CSLP SYSTEM
K000742 · KWQ
Synthes Spine
Orthopedic · 22d
Cleared Mar 29, 2000
MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT...
K992215 · DQA
Envitec-Wismar GmbH
Anesthesiology · 272d
Cleared Mar 29, 2000
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992554 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 243d
Cleared Mar 29, 2000
HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES
K993201 · KGO
Pamitex Industries Sdn Bhd
General Hospital · 187d
Cleared Mar 29, 2000
EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER
K994026 · IYN
Hitachi Medical Corp. of America
Radiology · 124d
Cleared Mar 28, 2000
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
K000013 · DXT
Acist Medical Systems
Cardiovascular · 85d
Cleared Mar 28, 2000
BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
K000495 · BSP
Ballard Medical Products
Anesthesiology · 42d