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
169153–169176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1979
VASCULIZER
K791418 · DPW
Diagnostics Intl.
Cardiovascular · 69d
Cleared Oct 04, 1979
ACCUNAMIC
K791636 · DRS
Sorensen Research
Cardiovascular · 44d
Cleared Oct 04, 1979
TEW BYPASS INSTRUMENTS & DISSECTING KIT
K791703 · GDI
Edward Weck, Inc.
General & Plastic Surgery · 37d
Cleared Oct 04, 1979
4200 PNEUMATIC MOUTH SHUTTER
K791705 · CCM
Hans Rudolph, Inc.
Anesthesiology · 37d
Cleared Oct 04, 1979
SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL
K791718 · ILJ
Universal-Kundle Corp.
Physical Medicine · 37d
Cleared Oct 04, 1979
BARRIER & FACE MASK WITH INNER FACING
K791719 · KKX
Surgikos, Inc.
General Hospital · 35d
Cleared Oct 04, 1979
FLOOR LINE INSTRUMENTS
K791741 · FZT
Edward Weck, Inc.
General & Plastic Surgery · 24d
Cleared Oct 04, 1979
BROOKS GALL BLADDER SCISSORS (SURG)
K791742 · FZT
Edward Weck, Inc.
General & Plastic Surgery · 24d
Cleared Oct 04, 1979
LECTROVAC, VALLEYLAB MODELS
K791752 · GEI
Valleylab, Inc.
General & Plastic Surgery · 29d
Cleared Oct 04, 1979
TEST PRESSURE GAUGE #6675-32
K791759 · KCY
Depuy, Inc.
General & Plastic Surgery · 29d
Cleared Oct 04, 1979
SALMONELLA SHIGELLA AGAR PLATE
K791786 · JSI
American Laboratory Supply, Inc.
Microbiology · 23d
Cleared Oct 04, 1979
MUELLER HINTON CHOCOLATE
K791815 · JTZ
Isle Media and Sterile Products, Inc.
Microbiology · 20d
Cleared Oct 04, 1979
VEIN GRAFT CANNULA
K791832 · DWF
D/P, Inc.
Cardiovascular · 16d
Cleared Oct 04, 1979
TECNOL STIRRUPS STRAP
K791859 · BWN
Tecnol New Jersey Wound Care, Inc.
General & Plastic Surgery · 16d
Cleared Oct 04, 1979
OXYGEN HOODS
K791861 · FOG
Ann Arbor Plastics, Inc.
Anesthesiology · 10d
Cleared Oct 04, 1979
HEART RATE COMPUTER
K791862 · DRT
Stanford Assoc., Inc.
Cardiovascular · 10d
Cleared Oct 04, 1979
STANDARD HEALTH BIKE MODEL 019
K791866 · ISD
Battle Creek Equipment Co.
Physical Medicine · 13d
Cleared Oct 04, 1979
PARKE-DAVIS TOTAL HIP PROSTHESIS
K791875 · DXQ
Warner-Lambert Co.
Cardiovascular · 13d
Cleared Oct 04, 1979
BAC JAC
K791919 · HST
Haggin Industries, Inc.
Neurology · 9d
Cleared Oct 04, 1979
PREHENSILE HAND
K791931 · IRA
Therapeutic Recreation Systems, Inc.
Physical Medicine · 7d
Cleared Oct 04, 1979
ROTH-KENNEDY PASSER
K791960 · HWQ
3M Company
Orthopedic · 3d
Cleared Oct 04, 1979
TOME'S #'S 1221,1222,1223,1314,6640,6642
K791980 · HNN
Edward Weck, Inc.
Ophthalmic · 9d
Cleared Oct 04, 1979
SWAN KNIFE NEEDLE 1.5MM CAT # 1170
K791981 · HNN
Edward Weck, Inc.
Ophthalmic · 9d
Cleared Oct 04, 1979
CANNULA'S CAT #'S 6636, 6624, 6625
K791982 · HMX
Edward Weck, Inc.
Ophthalmic · 9d