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

Filters: Cleared only ×
176,076 results
166849–166872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1980
OXY CUSTOM TRAY RESIN
K801780 · EBH
Oxy Dental Products, Inc.
Dental · 10d
Cleared Aug 07, 1980
HUMEROUS FRACTURE BRACE, ULNA FRACTURE
K801788 · IQI
Hosmer Dorrance Corp.
Physical Medicine · 9d
Cleared Aug 07, 1980
SCI-PHARM PAINT-ON RESTORATIVE
K801797 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 9d
Cleared Aug 07, 1980
COMPOSITE RESTORATIVE, PASTE/PASTE TYPE
K801798 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 9d
Cleared Aug 04, 1980
DEBRISAN (DEXTRANOMER) PASTE
K800737 · KOZ
Pharmaseal Laboratories
General & Plastic Surgery · 124d
Cleared Aug 04, 1980
WEBER-MAYO WRIST
K801157 · KWM
Depuy, Inc.
Orthopedic · 82d
Cleared Aug 04, 1980
FINGER, HAND & WRIST EXERCISER
K801453 · ION
Robert W. Slack
Physical Medicine · 41d
Cleared Aug 04, 1980
SPAN-AID BRIDGING PILLOW SYSTEM
K801518 · HKX
Span-America Medical Systems, Inc.
Ophthalmic · 34d
Cleared Aug 04, 1980
KERR CORE COMPOSITE
K801529 · EBF
Sybron Corp.
Dental · 33d
Cleared Aug 04, 1980
STERILE CAST PADDING
K801554 · HIX
Medi-Spec
Ophthalmic · 27d
Cleared Aug 04, 1980
COMPACT MODEL 360 GALVANIC EPILATOR
K801555 · KCW
Associated Electrolysis Group
General & Plastic Surgery · 27d
Cleared Aug 04, 1980
SURG-ASSIST
K801572 · FWZ
Medmetric Corp.
General & Plastic Surgery · 26d
Cleared Aug 04, 1980
AUTO SUTURE DISP. 30, ETC. & SURG. STAP
K801589 · FHM
United States Surgical, A Division of...
General & Plastic Surgery · 24d
Cleared Aug 04, 1980
AUTO SUTURE DISPOSABLE GIA SURG. STAPLER
K801590 · FHM
United States Surgical, A Division of...
General & Plastic Surgery · 24d
Cleared Aug 04, 1980
PFT CALIBRATOR
K801597 · BZC
Spital Medical, Inc.
Anesthesiology · 41d
Cleared Aug 04, 1980
PATHFINDER ELECTRODIAGNOSTIC SYSTEM
K801604 · GWK
Nicolet Biomedical Instruments
Neurology · 21d
Cleared Aug 04, 1980
CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR
K801610 · GCZ
Edward Weck, Inc.
General & Plastic Surgery · 20d
Cleared Aug 04, 1980
DEEP BALFOUR BLADE FOR WILKINSON RETRACT
K801611 · GAD
Edward Weck, Inc.
General & Plastic Surgery · 20d
Cleared Aug 04, 1980
FRAZIER-FERGUSON SUCTION TUBES (DISP.)
K801612 · GCY
Edward Weck, Inc.
General & Plastic Surgery · 20d
Cleared Aug 04, 1980
NON-CONDUCTIVE SHOE COVERS
K801616 · FXP
Procter & Gamble Mfg. Co.
General Hospital · 20d
Cleared Aug 04, 1980
CONDUCTIVE SHOE COVERS
K801617 · FXP
Procter & Gamble Mfg. Co.
General Hospital · 20d
Cleared Aug 04, 1980
MIST2GEN TEMPTROL 10
K801619 · BTT
Mistogen Equipment Co.
Anesthesiology · 20d
Cleared Aug 04, 1980
THE BELLCO FISTULA NEEDLES
K801632 · FIE
Bellco Artifidial Organ Spec., Inc.
Gastroenterology & Urology · 20d
Cleared Aug 04, 1980
BIOBRANE BRAND TEMPORARY WOUND-DRESSING
K801635 · FRO
Hall-Woodroof, Inc.
General & Plastic Surgery · 20d