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
84841–84864 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1999
MODIFICATION TO LINER II: SOFT RELINE LIQUID
K991687 · EBI
Bosworth Co.
Dental · 143d
Cleared Oct 07, 1999
AIRFLOW HANDY
K991857 · EFB
Electro Medical Systems, Inc.
Dental · 128d
Cleared Oct 07, 1999
REFRESH CONTACTS LUBRICATING AND REWETTING DROPS
K992028 · LPN
Allergan, Inc.
Ophthalmic · 113d
Cleared Oct 07, 1999
INTRODUCER SHEATH, VESSEL DILATOR
K992309 · DYB
Boston Scientific Corp
Cardiovascular · 90d
Cleared Oct 07, 1999
BEACON-P, MODEL 211059
K992335 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 86d
Cleared Oct 07, 1999
EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
K992450 · KPS
Emory University
Radiology · 77d
Cleared Oct 07, 1999
CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000
K992575 · LLZ
Infimed, Inc.
Radiology · 66d
Cleared Oct 07, 1999
ECG MINIMONITOR, MODEL CG-5000
K992696 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 56d
Cleared Oct 07, 1999
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE
K992869 · ETN
Xomed, Inc.
Ear, Nose, Throat · 43d
Cleared Oct 07, 1999
REFERENCE
K992966 · EBF
Espe Dental AG
Dental · 35d
Cleared Oct 07, 1999
BAHO AUTOCLAVABLE CYSTOSCOPE
K992983 · FAJ
Innovative Endoscopy Components, LLC
Gastroenterology & Urology · 34d
Cleared Oct 07, 1999
TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
K993038 · JAA
Toshiba America Medical Systems, In.C
Radiology · 27d
Cleared Oct 06, 1999
SERAQUEST EB VAC IGM
K990977 · LJN
Quest Intl., Inc.
Microbiology · 197d
Cleared Oct 06, 1999
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE,...
K991474 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 162d
Cleared Oct 06, 1999
SUPER SOOTHER
K991914 · FLL
Mart Tiller Corp.
General Hospital · 121d
Cleared Oct 06, 1999
MODIFICATION TO IMX HOMOCYSTEINE
K992274 · LPS
Axis Biochemicals, Asa
Chemistry · 92d
Cleared Oct 06, 1999
QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C
K992685 · MVO
Phamatech
Toxicology · 57d
Cleared Oct 06, 1999
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K992861 · LYZ
Shijiazhuang Great Eagle Plastic...
General Hospital · 42d
Cleared Oct 06, 1999
SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
K992922 · LYZ
Shijiazhuang Hongray Plastic Products...
General Hospital · 37d
Cleared Oct 06, 1999
LUCITONE FRS FLEXIBEL DENTAL RESIN
K992956 · EBI
Dentsply Intl.
Dental · 34d
Cleared Oct 06, 1999
ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW
K993004 · JDS
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Oct 06, 1999
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
K993064 · KDI
Gambro Renal Care Products
Gastroenterology & Urology · 23d
Cleared Oct 06, 1999
REDI-SCREEN
K993100 · DJC
Redwood Biotech, Inc.
Toxicology · 20d
Cleared Oct 05, 1999
PREFERENCE TREATMENT SYSTEM
K983793 · LNH
Northwest Medical Physics Equipment,...
Radiology · 343d