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
153721–153744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 1984
MENSTRUAL ASPIRATION KIT
K840383 · HHI
Intl. Medical Technologies, Inc.
Obstetrics & Gynecology · 91d
Cleared Apr 30, 1984
DIAGNOSTIC DILATATION & MENSTRUAL KIT
K840384 · HHI
Intl. Medical Technologies, Inc.
Obstetrics & Gynecology · 91d
Cleared Apr 30, 1984
ELECTRO-MESH GLOVE
K840395 · GXY
Whiting & Davis Co.
Neurology · 91d
Cleared Apr 30, 1984
ELECTRO-MESH WRAP
K840396 · GXY
Whiting & Davis Co.
Neurology · 91d
Cleared Apr 30, 1984
AMETHERM
K840526 · FMZ
Egnell, Inc.
General Hospital · 83d
Cleared Apr 30, 1984
MAGNE-DENT
K840600 · EGG
Magne-Dent
Dental · 80d
Cleared Apr 30, 1984
INFANT STAR VENTILATOR
K840865 · CBK
Infrasonics Corp.
Anesthesiology · 63d
Cleared Apr 30, 1984
FACTOR DEFICIENT SUBSTRATE PLASMA II
K840927 · GGP
Diatech, Inc.
Hematology · 59d
Cleared Apr 30, 1984
FACTOR DEFICIENT SUBSTRATE PLASMA VIII
K840928 · GGP
Diatech, Inc.
Hematology · 59d
Cleared Apr 30, 1984
PROVIDER INFUSION SET
K841017 · FRN
Pancretec, Inc.
General Hospital · 52d
Cleared Apr 30, 1984
SHERIDAN YSI/SONATEMP
K841098 · BZT
Sheridan Catheter Corp.
Anesthesiology · 48d
Cleared Apr 30, 1984
NEUROTRAC
K841110 · GWK
Interspec, Inc.
Neurology · 76d
Cleared Apr 30, 1984
C-18
K841267 · EBF
Pentron Corp.
Dental · 35d
Cleared Apr 30, 1984
CALCIUM CHLORIDE
K841522 · GGW
Diatech, Inc.
Hematology · 18d
Cleared Apr 30, 1984
COMMUNI-TRACH TUBE
K841546 · BTO
Implant Technology, Inc.
Anesthesiology · 14d
Cleared Apr 30, 1984
UNIFILTER ANESTHESIA & RESPIRATORY FILT
K841581 · CAH
Dupaco, Inc.
General Hospital · 13d
Cleared Apr 27, 1984
HYDRON WOUND DRESSING FAST SEAT KIT
K832699 · FRO
National Patent Development Corp.
General & Plastic Surgery · 261d
Cleared Apr 27, 1984
STERILE SUTURE BOOTS
K834135 · KDD
Devon Industries, Inc.
General & Plastic Surgery · 148d
Cleared Apr 27, 1984
PICKER MYELOGRAM TRAY-PMS MYELOGRAM
K841217 · FMI
Professional Medical Systems
General Hospital · 36d
Cleared Apr 26, 1984
OFTALMOGRAF
K833024
Universal Instruments Corp.
Ophthalmic · 233d
Cleared Apr 25, 1984
BLOOD MONITOR BMM 10-4
K831404 · LLB
Gambro, Inc.
Gastroenterology & Urology · 359d
Cleared Apr 25, 1984
SHARPLAN #734 LASER SURGICAL UNIT
K832550 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 268d
Cleared Apr 25, 1984
ENDO BITE BLOCK
K833491 · KTI
American Endoscopy, Inc.
Ear, Nose, Throat · 201d
Cleared Apr 25, 1984
LIGHT CURED RESIN BONDED CERAMIC
K833797 · EBF
3M Company
Dental · 176d