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
124297–124320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1990
HANDI-TRACTION
K904862 · ITI
Handi-Trak, Inc.
Physical Medicine · 7d
Cleared Nov 02, 1990
FRESENIUS AS 104 CELL SEPARATOR
K895435 · LKN
Fresenius USA, Inc.
Gastroenterology & Urology · 421d
Cleared Nov 02, 1990
UNOMETER 500
K896732 · EXR
Unoplast A/S
Gastroenterology & Urology · 337d
Cleared Nov 02, 1990
MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
K900371 · FAE
Mentor Corp.
Gastroenterology & Urology · 280d
Cleared Nov 02, 1990
HEVEASHIELD EXAMINATION GLOVES
K902700 · LYY
Pacificlink Export
General Hospital · 135d
Cleared Nov 02, 1990
LATEX EXAMINATION GLOVES
K902956 · LYY
Pacificlink Export Industries Private...
General Hospital · 120d
Cleared Nov 02, 1990
AFGA VIDEO IMAGER, VARIOUS MODELS
K903238 · LMC
Enhanced Imaging Technologies, Inc.
Radiology · 107d
Cleared Nov 02, 1990
ALLERGY CONTROL COVERS
K903382 · FMW
Allergy Control Products, Inc.
General Hospital · 98d
Cleared Nov 02, 1990
UNNA-SLEEVE(TM)
K903532 · LLK
Aci Medical, Inc.
General Hospital · 88d
Cleared Nov 02, 1990
BRADLEY TENACULUM HOLDER
K903649 · KDC
Marlo Surgical Technology
General & Plastic Surgery · 81d
Cleared Nov 02, 1990
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K903763 · JAK
General Electric Co.
Radiology · 74d
Cleared Nov 02, 1990
PERMA MESH
K904089 · EJF
Lancer Orthodontics, Inc.
Dental · 57d
Cleared Nov 02, 1990
C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE
K904094 · EJF
Lancer Orthodontics, Inc.
Dental · 57d
Cleared Nov 02, 1990
CYTOSMEAR BRUSH
K904160 · HHI
Brooke Intl.
Obstetrics & Gynecology · 52d
Cleared Nov 02, 1990
HOLDER, DENTAL BUR, ALUMINUM
K904278 · EJI
Maverick Surgical, Inc.
Dental · 46d
Cleared Nov 02, 1990
SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015
K904479 · HRX
Percutaneous Technologies
Orthopedic · 31d
Cleared Nov 02, 1990
SERACON CR REFERENCE
K904503 · JJX
Bhp Diagnostix, Inc.
Chemistry · 31d
Cleared Nov 02, 1990
AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008
K904666 · JLW
Amersham Corp.
Chemistry · 18d
Cleared Nov 02, 1990
QBC SYSTEM MCHC
K904675 · JPJ
Bd Becton Dickinson Vacutainer...
Hematology · 21d
Cleared Nov 02, 1990
QUALICHECK 3
K904733 · JJS
Radiometer America, Inc.
Chemistry · 16d
Cleared Nov 01, 1990
VASCUMED EZ Y-CONNECTOR
K902741 · DTL
Vascumed Systems
Cardiovascular · 132d
Cleared Nov 01, 1990
AMICON DIAFILTER 30 HEMOCONCENTRATOR
K902837 · KDI
Amicon, Inc.
Gastroenterology & Urology · 126d
Cleared Nov 01, 1990
TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE
K902958 · JOJ
Board of Directors, Albert Browne , Ltd.
General Hospital · 119d
Cleared Nov 01, 1990
TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III
K904141 · JJY
Medical Analysis Systems, Inc.
Chemistry · 56d