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

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175,820 results
150817–150840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 1984
VIS-1000 VIDEO SYSTEM
K843806 · KQM
Vistek Corp.
General & Plastic Surgery · 76d
Cleared Dec 12, 1984
ESCHMANN TDB50 BIPOLAR COAGULATION
K844004 · GEI
Storz Instrument Co.
General & Plastic Surgery · 61d
Cleared Dec 12, 1984
DOSIMETRIC RELEASE IN THE PROCESSING OF GAMMA STER
K844462
Washington-Greene County Branch...
General & Plastic Surgery · 27d
Cleared Dec 12, 1984
80 MG/DL GLUCOSE CONTROL
K844581 · JIS
Boehringer Mannheim Corp.
Chemistry · 19d
Cleared Dec 12, 1984
C.A.S.E. CONTAINER
K844652 · FSM
General Medical Co.
General & Plastic Surgery · 13d
Cleared Dec 12, 1984
SHARP COLLECTION SYSTEM-SHARP-A-GATOR
K844654 · MMK
Devon Industries, Inc.
General Hospital · 13d
Cleared Dec 12, 1984
DIXON SCISSORS, STARINLESS STEEL, OPERATING TYPE
K844667
William Dixon Co.
Dental · 12d
Cleared Dec 12, 1984
GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED
K844720 · JQB
Data Medical Associates, Inc.
Chemistry · 8d
Cleared Dec 11, 1984
DEL MAR AVIONICS 509 NEUROCORDER AMBUL
K841654 · DSH
Del Mar Avionics
Cardiovascular · 232d
Cleared Dec 11, 1984
ULTRASONIC LITHOTRIPTOR 300A
K842024 · FEO
Fibra Sonics, Inc.
Gastroenterology & Urology · 207d
Cleared Dec 11, 1984
MULTIPLE LENS, SPECTACLES, CUSTOM
K842187 · HQG
Pavuna , Ltd.
Ophthalmic · 190d
Cleared Dec 11, 1984
MULTIPLE-LENS, SPECTACLES, CUSTOM
K842188 · HQE
Gold Cadillac Co.
Ophthalmic · 190d
Cleared Dec 11, 1984
MULTIPLE LENS, SPECTACLES CUSTOM
K842189 · HQG
Hanmy Optical Industrial Co.
Ophthalmic · 190d
Cleared Dec 11, 1984
CARE 5000 CENTRAL MONITOR MS5220 ETC.
K842582 · DRT
Care Monitoring Systems
Cardiovascular · 161d
Cleared Dec 11, 1984
WAKO AUTOMATED REAGENTS FOR HITACHI 705
K842847 · CJW
Wako Chemicals USA, Inc.
Hematology · 144d
Cleared Dec 11, 1984
COOPERVISION SYSTEM VI
K842945 · HQC
CooperVision, Inc.
Ophthalmic · 139d
Cleared Dec 11, 1984
KARL STORZ 27086KC ULTRASONIC LITHOTRI
K843101 · FEO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 126d
Cleared Dec 11, 1984
OVUSTICK SELF-TEST
K843284 · CEP
Monoclonal Antibodies, Inc.
Chemistry · 113d
Cleared Dec 11, 1984
CHEW-DENT
K843406 · JEW
Senair-Mot
Dental · 102d
Cleared Dec 11, 1984
CORNING 614 NA/K ANALYZER
K843530 · JGS
Corning Medical & Scientific
Chemistry · 95d
Cleared Dec 11, 1984
HEARING AID - ALL IN THE EAR
K843574 · ESD
Auralogics Lab
Ear, Nose, Throat · 91d
Cleared Dec 11, 1984
PROM NAID
K843581 · ITH
Lossing Orthopedic, Inc.
Physical Medicine · 91d
Cleared Dec 11, 1984
WOODLYN CLASSIC CATARACT ACUITY TEST
K843812 · HLI
Woodlyn, Inc.
Ophthalmic · 74d
Cleared Dec 11, 1984
CANMED 103 9300 ELECTRODE
K844097 · GXY
Medtronic Vascular
Neurology · 49d