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
138193–138216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1987
UNIPORT MODELS SD-90, TD-60, TD-70 & TD-90
K873575 · LJT
Healthcare Technologies, Inc.
General Hospital · 80d
Cleared Nov 13, 1987
REVISED LABELING FOR ABUSCREEN EIA BARBITURATE
K874210 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 28d
Cleared Nov 13, 1987
ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN
K874213 · DIO
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 28d
Cleared Nov 13, 1987
EMIT TOBRAMYCIN ASSAY
K874223 · KLB
Syva Co.
Toxicology · 28d
Cleared Nov 13, 1987
ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000
K874243 · GAD
Pilling Co.
General & Plastic Surgery · 28d
Cleared Nov 13, 1987
REVISED LABELING FOR BENZODIAZEPINE TEST KIT
K874265 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR BARBITURATE TEST KIT
K874266 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR PCP TEST KIT
K874267 · LCM
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR MORPHINE TEST KIT
K874268 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR LSD TEST KIT
K874270 · DLB
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR COCAINE/COCAINE META. TEST
K874271 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR METHAQUALONE TEST KIT
K874272 · KXS
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR AMPHETAMINE TEST KIT
K874273 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
REVISED LABELING FOR AMPHETAMINE TEST KIT
K874274 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Nov 13, 1987
LIGATURE CARRIER/PACKER, HYDROXYLAPATITE
K874342 · GEJ
Cox-Uphuff Intl.
General & Plastic Surgery · 24d
Cleared Nov 13, 1987
SURGICAL PREP RAZOR
K874370 · LWK
Derma-Safe Co.
General & Plastic Surgery · 18d
Cleared Nov 12, 1987
NOVO BMC-LAB 23, BONE DENSITOMETER
K864299 · KGI
Scan Detectronic Laboratories, Inc.
Radiology · 377d
Cleared Nov 12, 1987
HEARING AID (ALL-IN-THE-EAR)
K873490 · ESD
Kerr Hearing Aid Laboratory
Ear, Nose, Throat · 73d
Cleared Nov 12, 1987
TUBING, POLYETHYLENE
K873597 · DXT
Coeur Laboratories, Inc.
Cardiovascular · 69d
Cleared Nov 12, 1987
DIAMOND-LUSTER DENTAL POLISHING PASTE
K873686 · EJR
Scientific Pharmaceuticals, Inc.
Dental · 59d
Cleared Nov 12, 1987
NOVA STREP A
K873784 · GTZ
Synbiotics Corp.
Microbiology · 56d
Cleared Nov 12, 1987
CLEARFIL PORCELAIN REPAIR SYSTEM
K873886 · EBF
Kuraray Co.
Dental · 50d
Cleared Nov 12, 1987
MODEL A-72, BEHIND-THE-EAR HEARING AID
K874325 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 22d
Cleared Nov 12, 1987
TITANIUM SUCTION TIP
K874401 · EHZ
Implant Innovations International, Inc.
Dental · 15d