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
151369–151392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 1984
SERIES I/S INFECTIONS
K844289 · KTN
American Dade
Immunology · 14d
Cleared Nov 16, 1984
PERSONAL CL SINGLE-CHANNEL ELECTROCAR
K842123 · DSI
Parexel Intl. Corp.
Cardiovascular · 171d
Cleared Nov 16, 1984
URITROL-M
K842808 · KNT
The Washington Group, Inc.
Gastroenterology & Urology · 121d
Cleared Nov 16, 1984
HAP ACETABULAR CUP
K843190 · JDI
Depuy, Inc.
Orthopedic · 95d
Cleared Nov 16, 1984
PHARMA-PLAST CONNECTING TUBE TYPE SUCT-
K843470 · BYY
Zimmar Consulting , Ltd.
General Hospital · 71d
Cleared Nov 16, 1984
ASN MONITOR SINGLE NEEDLE MONITOR
K843531 · KOC
Organon Teknika Corp.
Gastroenterology & Urology · 70d
Cleared Nov 16, 1984
UNILYTE A
K843623 · FKQ
Medical Enterprises, Ltd.
Gastroenterology & Urology · 87d
Cleared Nov 16, 1984
FOAM CARE ONE STEP PREP
K843636 · GEC
Ballard Medical Products
General & Plastic Surgery · 60d
Cleared Nov 16, 1984
STORZ ASPIRATION MACHINE SAM 5000
K843644 · BTA
Storz Instrument Co.
General & Plastic Surgery · 60d
Cleared Nov 16, 1984
TRANQUILITY
K843869 · EYQ
Principle Business Ent.
Gastroenterology & Urology · 45d
Cleared Nov 16, 1984
PERSONAL AMPLIFIER SILENCER
K843980 · ESD
Electone, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 16, 1984
SCD STERILE CONNECTION DEVICE
K844144 · FKX
E.I. Dupont DE Nemours & Co., Inc.
Gastroenterology & Urology · 24d
Cleared Nov 15, 1984
INTERMEDICS/GRASEBY DYNAMICS MS 36
K843331 · FRN
Intermedics, Inc.
General Hospital · 80d
Cleared Nov 15, 1984
ARGYLE SILICONE CENTRAL VENOUS CATH-
K843450 · LJS
Sherwood Medical Co.
General Hospital · 71d
Cleared Nov 15, 1984
OHMEDA PEEP VALVE FOR GMS ABSORBER
K843835 · BYE
Ohmeda Medical
Anesthesiology · 45d
Cleared Nov 15, 1984
TITANIUM HIP 1019
K843909 · JDI
Depuy, Inc.
Orthopedic · 43d
Cleared Nov 15, 1984
ANAESLOCK THREE VAPORIZER INTERLOCK HVA003
K843993 · CAD
Southmedic, Inc.
Anesthesiology · 35d
Cleared Nov 15, 1984
AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
K844149 · CAI
Ambu, Inc.
Anesthesiology · 22d
Cleared Nov 14, 1984
CRYO MASSAGE CUP
K843203
Cryo Therapy
Physical Medicine · 92d
Cleared Nov 14, 1984
AGGLUTINATION TEST FOR TOTAL IGE
K843369 · DGC
Scientific Research
Immunology · 78d
Cleared Nov 14, 1984
KANIEVSKI SENSORY AID OR DEVICE
K843433 · LRA
Spectro Industries, Inc.
Ear, Nose, Throat · 71d
Cleared Nov 14, 1984
MANDIBULATOR JAW POSITIONER
K843705 · DYJ
A Company, Inc.
Dental · 54d
Cleared Nov 14, 1984
VENT-A-CAST
K843780 · LGF
Orthopedic Technology, Inc.
Orthopedic · 49d
Cleared Nov 14, 1984
SIROGNATHOGRAPH
K843951 · NFS
Siemens Medical Solutions USA, Inc.
Dental · 36d