Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
151129–151152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 1984
ANAESLOCK THREE VAPORIZER INTERLOCK HVA003
K843993 · CAD
Southmedic, Inc.
Anesthesiology · 35d
Cleared Nov 15, 1984
AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
K844149 · CAI
Ambu, Inc.
Anesthesiology · 22d
Cleared Nov 14, 1984
CRYO MASSAGE CUP
K843203
Cryo Therapy
Physical Medicine · 92d
Cleared Nov 14, 1984
AGGLUTINATION TEST FOR TOTAL IGE
K843369 · DGC
Scientific Research
Immunology · 78d
Cleared Nov 14, 1984
KANIEVSKI SENSORY AID OR DEVICE
K843433 · LRA
Spectro Industries, Inc.
Ear, Nose, Throat · 71d
Cleared Nov 14, 1984
MANDIBULATOR JAW POSITIONER
K843705 · DYJ
A Company, Inc.
Dental · 54d
Cleared Nov 14, 1984
VENT-A-CAST
K843780 · LGF
Orthopedic Technology, Inc.
Orthopedic · 49d
Cleared Nov 14, 1984
SIROGNATHOGRAPH
K843951 · NFS
Siemens Medical Solutions USA, Inc.
Dental · 36d
Cleared Nov 14, 1984
LINK ACETABULAR MESH
K844225 · FTM
Waldemar Link GmbH & Co. KG
General & Plastic Surgery · 13d
Cleared Nov 13, 1984
N-CHANNEL
K834212 · LOS
Philips Medical Systems (Cleveland),...
Cardiovascular · 344d
Cleared Nov 13, 1984
CANNULA INTRODUCER
K843118 · DYB
Cardiovascular Research, Inc.
Cardiovascular · 97d
Cleared Nov 13, 1984
COULTER COUNTER MODEL ZM
K843164 · GKL
Coulter Electronics, Inc.
Hematology · 92d
Cleared Nov 13, 1984
TRI-MED 610 CAPNOSTAT GAS ANALYZER
K843285 · CCK
Tri-Med, Inc.
Anesthesiology · 84d
Cleared Nov 13, 1984
DELTANODE, MEGA DELTA, DELTA LINK-
K843558 · IYX
Computer Design & Applications, Inc.
Radiology · 64d
Cleared Nov 13, 1984
TANDEM - EPRL
K843804 · CFT
Hybritech, Inc.
Chemistry · 47d
Cleared Nov 13, 1984
MICRO HEMATOCRIT CAPILLARY TUBES
K843892 · GIO
Abco Dealers, Inc.
Hematology · 41d
Cleared Nov 13, 1984
ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT
K844045 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 27d
Cleared Nov 13, 1984
CODE-A-WALL SERIES 1-250 INOCULUM TRAY
K844058
Plastic Injectors, Inc.
Microbiology · 26d
Cleared Nov 13, 1984
POS COMBO PANEL
K844086 · JTO
American Micro Scan
Microbiology · 22d
Cleared Nov 13, 1984
UREA NITROGEN REAGENT SET
K844156 · CDW
Livonia Diagnostics, Inc.
Chemistry · 20d
Cleared Nov 09, 1984
PERFOURM
K842324 · ELW
Cutter Laboratories, Inc.
Dental · 149d
Cleared Nov 09, 1984
SLS 3500 LED VISUAL STIMULATOR
K842381 · GWE
Nihon Kohden America, Inc.
Neurology · 144d
Cleared Nov 09, 1984
TITAN GEL ISO DOT LDH KIT
K842669 · CFE
Helena Laboratories
Chemistry · 122d
Cleared Nov 09, 1984
A.S.P.C./CLEARSOUND
K842832 · ESD
Asl, Inc.
Ear, Nose, Throat · 112d