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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
151393–151416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 09, 1984
ORTHODONTIC WIRE
K843722 · DZC
Arthur L. Wool
Dental · 46d
Cleared Nov 09, 1984
UNITEK CONVERTIBLE CAP REMOVER TOOL
K843742 · JEX
Unitek Corp.
Dental · 45d
Cleared Nov 09, 1984
BEHIND-THE-EAR 123 VTH
K843791 · ESD
Danavox, Inc.
Ear, Nose, Throat · 43d
Cleared Nov 09, 1984
RIONET HEARING AID HB-73
K844000 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 28d
Cleared Nov 09, 1984
TRIGLYCERIDE REAGENT
K844032 · CDT
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Nov 09, 1984
FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS
K844047 · JIT
Fisher Diagnostics
Chemistry · 23d
Cleared Nov 09, 1984
VOLUMATIC
K844169 · KCD
Glaxo, Inc.
Ear, Nose, Throat · 15d
Cleared Nov 09, 1984
INORGANIC PHOSPHORUS REAGENT SET
K844182 · CEO
Livonia Diagnostics, Inc.
Chemistry · 14d