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
138553–138576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1987
YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN
K872700 · GPW
Sita, Inc.
Microbiology · 100d
Cleared Oct 15, 1987
DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.
K872770 · DYG
Nova Medical Specialties
Cardiovascular · 93d
Cleared Oct 15, 1987
NIDEK ADC-8000 LASER SYSTEM
K872846 · HQF
Nidek, Inc.
Ophthalmic · 87d
Cleared Oct 15, 1987
WILLIAMS VERTEBRAL SPREADER
K872858 · HXP
Ace Medical Co.
Orthopedic · 86d
Cleared Oct 15, 1987
ACROMED BONE PLATE BENDER
K872949 · HXW
Buckman Co., Inc.
Orthopedic · 79d
Cleared Oct 15, 1987
W-J STERILE TRI-FUNCTIONAL CONTACT LENS SOLUTION
K872973 · LPN
Wesley Jessen Corp.
Ophthalmic · 77d
Cleared Oct 15, 1987
KEANE MOBILITY BED
K873047 · IKZ
Surgi-Med, Inc.
Physical Medicine · 72d
Cleared Oct 15, 1987
NEER-III GLENOID RESURFACING PROSTHESIS
K873104 · KWT
Kirschner Medical Corp.
Orthopedic · 69d
Cleared Oct 15, 1987
VICOR, MODEL 410A
K873202 · DXY
Tpl-Cordis, Inc.
Cardiovascular · 63d
Cleared Oct 15, 1987
IDENTICULT-BL
K873509 · JTO
Scott Laboratories, Inc.
Microbiology · 45d
Cleared Oct 15, 1987
NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE.
K873620 · KWT
Kirschner Medical Corp.
Orthopedic · 37d
Cleared Oct 15, 1987
NEER-III SOLID KEEL GLENOID RESURFACING PROSTHESIS
K873621 · KWT
Kirschner Medical Corp.
Orthopedic · 37d
Cleared Oct 15, 1987
STANDARD KNIFE, DISPOSABLE #TM-1610
K873712 · HTS
Arthropedics, Inc.
Orthopedic · 30d
Cleared Oct 15, 1987
LABELING CHANGES COAT-A-COUNT METHADONE IN URINE
K873750 · DJR
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE
K873751 · DIO
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY
K873752 · DIO
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE
K873753 · LDJ
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE BARBITURATES IN URINE
K873754 · DIS
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE AMPHETAMINE DOUBLE ANTIBODY
K873755 · DKZ
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE
K873756 · LCM
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE
K873757 · DJG
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COAT-A-COUNT SERUM MORPHINE
K873758 · DJG
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
LABELING CHANGE COAT-A-COUNT METHAQUALONE
K873759 · KXS
Diagnostic Products Corp.
Toxicology · 41d
Cleared Oct 15, 1987
MODIFICATION RUBELLA IGM EIA TEST KIT
K873780 · LFX
Labsystems, Inc.
Microbiology · 35d