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
169177–169200 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1979
SPATULA'S #'S 7618,7248,7240,7242,5108
K791983 · HND
Edward Weck, Inc.
Ophthalmic · 9d
Cleared Oct 04, 1979
HOOKS #'S 7600,7602,7603,7616
K791985 · HNQ
Edward Weck, Inc.
Ophthalmic · 9d
Cleared Oct 04, 1979
FIX. & LENS FOR. #'S 3510,3512,3248,3795
K791986 · HNR
Edward Weck, Inc.
Ophthalmic · 9d
Cleared Oct 04, 1979
VASCULAR FORCEPS & CLAMPS
K791987 · GEN
Edward Weck, Inc.
General & Plastic Surgery · 9d
Cleared Oct 02, 1979
INFUSION NEEDLE SET
K791529 · FPA
I.M.P. Group , Ltd.
General Hospital · 53d
Cleared Oct 02, 1979
COLOPLAST CARBON GAS FILTER
K791581 · EXB
C.R. Bard, Inc.
Gastroenterology & Urology · 48d
Cleared Oct 02, 1979
BE-SURE
K791609 · JHJ
Biologics Intl., Inc.
Chemistry · 53d
Cleared Oct 02, 1979
VICKERS MEDICAL MODEL 112 TREONIC DC2
K791645 · FKW
Vickers America Medical Corp.
Gastroenterology & Urology · 40d
Cleared Oct 02, 1979
CUSTOM DRESSING CHANGE TRAYS
K791738 · FMC
Sterile Design, Inc.
General Hospital · 33d
Cleared Oct 02, 1979
ULTIPOR BLOOD FILTER EXTRA-CORPOREAL
K791748 · DTM
Pall Biomedical Products Co.
Cardiovascular · 22d
Cleared Oct 02, 1979
IPAG MICRONOVA INTERFACE #781111
K791753 · DXG
Robinton Corp.
Cardiovascular · 27d
Cleared Oct 02, 1979
ARRHYTHMIA II EDITOR
K791776 · DQK
Spacelabs, Inc.
Cardiovascular · 22d
Cleared Oct 02, 1979
MEDTRONIC MODEL 9410 TELETRACE RECEIVER
K791778 · DXH
Medtronic Vascular
Cardiovascular · 22d
Cleared Oct 02, 1979
SHILEY QUICK DISCONNECT ASSEMBLY
K791829 · KRI
Shiley, Inc.
Cardiovascular · 15d
Cleared Oct 02, 1979
NURITE II VRM SINGLE (ELEC. NERVE STIM)
K791833 · GZJ
Bio-Medical Systems Corp.
Neurology · 15d
Cleared Oct 02, 1979
NURITE II VRM DUAL (ELEC. NERVE STIM.)
K791834 · GZJ
Bio-Medical Systems Corp.
Neurology · 15d
Cleared Oct 02, 1979
CRITIFLO & CRITIFLO DOME
K791844 · KRA
Gould, Inc.
Cardiovascular · 13d
Cleared Oct 02, 1979
DISPOSSABLE SUCTION TUBE, 6 FRENCH
K791846 · DTS
Dlp, Inc.
Cardiovascular · 13d
Cleared Oct 02, 1979
ASPRI-LUKE
K791847 · BYZ
Medical Marketing Group
General Hospital · 13d
Cleared Oct 02, 1979
MAC LEE ENEMAD
K791863 · FCE
Mac Lee Medical Products
Gastroenterology & Urology · 8d
Cleared Oct 02, 1979
JELCO WINGED INTRAVASCULAR CATHETER
K791918 · FOZ
Jelco Laboratories
General Hospital · 7d
Cleared Oct 01, 1979
INTRA-AORTIC BALLOON, TYPE S
K790775 · DSP
Datascope Corp.
Cardiovascular · 164d
Cleared Oct 01, 1979
PLASTIC SHOWER GUARD
K791646 · KIA
B & F Medical Products, Inc.
General Hospital · 38d
Cleared Oct 01, 1979
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY
K791663 · CDP
Immuchem Corp.
Chemistry · 41d