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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
143353–143376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1986
ANU-RX
K862490 · LKX
J. & Jp., Inc.
Gastroenterology & Urology · 48d
Cleared Aug 18, 1986
ULTRACAST
K862499 · EJH
Ultratek
Dental · 48d
Cleared Aug 18, 1986
A.C.L. GUIDE KIT
K862564 · FZX
Aspen Laboratories, Inc.
General & Plastic Surgery · 46d
Cleared Aug 18, 1986
PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
K862647 · DSK
Ivy Biomedical Systems, Inc.
Cardiovascular · 38d
Cleared Aug 18, 1986
MODIFIED DEODORANT MAXITHINS PANTY SHIELDS
K862675 · HHL
Tambrands, Inc.
Obstetrics & Gynecology · 35d
Cleared Aug 18, 1986
V. MUELLER (R) GOOSENECK CIRCULAR STAPLER
K862772 · GAG
American V. Mueller
General & Plastic Surgery · 27d
Cleared Aug 18, 1986
SPECTRUM POLYCORD I RECORDER SYSTEM
K862776 · DSH
Cardionics, Inc.
Cardiovascular · 27d
Cleared Aug 18, 1986
ABC-1000 SMALL JOINT REAMERS
K862933 · HTO
Instrumentation Industries, Inc.
Orthopedic · 14d
Cleared Aug 15, 1986
HA-2000 REAL EAR SPECTROSCOPE
K862026 · ETW
And/Or Corp.
Ear, Nose, Throat · 79d
Cleared Aug 15, 1986
RUSSIAN THISTLE ALLERGEN DISC
K862176 · DHB
Immuno Nuclear Corp.
Immunology · 67d
Cleared Aug 15, 1986
COTTONWOOD ALLERGEN DISC
K862265 · DHB
Immuno Nuclear Corp.
Immunology · 63d
Cleared Aug 15, 1986
OSTEOGRAF/AR AND OSTEOGRAF/AR+
K862324 · LYC
Coors Biomedical Co.
Dental · 57d
Cleared Aug 15, 1986
PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM
K862674 · JZT
Hybritech, Inc.
Immunology · 32d
Cleared Aug 15, 1986
MODIFIED SUPER DEODORANT MAXITHINS PADS
K862676 · HHL
Tambrands, Inc.
Obstetrics & Gynecology · 32d
Cleared Aug 15, 1986
MODIFIED MAXITHINS PANTY SHIELDS UNSCENTED
K862677 · HHD
Tambrands, Inc.
Obstetrics & Gynecology · 32d
Cleared Aug 15, 1986
MODIFIED REGULAR DEODORANT MAXITHINS PADS
K862678 · HHL
Tambrands, Inc.
Obstetrics & Gynecology · 32d
Cleared Aug 15, 1986
MODIFIED SUPER MAXITHINS PADS, UNSCENTED
K862679 · HHD
Tambrands, Inc.
Obstetrics & Gynecology · 32d
Cleared Aug 15, 1986
MODIFIED REGULAR MAXITHINS PADS, UNSCENTED
K862680 · HHD
Tambrands, Inc.
Obstetrics & Gynecology · 32d
Cleared Aug 15, 1986
AUDIOMETER/MASTER HEARING AID MF6
K862770 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Aug 15, 1986
TREACE DRILL SYSTEM
K862807 · ERL
Treace Medical, Inc.
Ear, Nose, Throat · 23d
Cleared Aug 15, 1986
CAPPEL DIAGNOSTICS ANA KIT
K862821 · DHN
Cappel Diagnostics, Inc.
Immunology · 21d
Cleared Aug 15, 1986
RESISTAL P
K862870 · EJH
Degussa Dental, Inc.
Dental · 17d
Cleared Aug 15, 1986
JUNE GRASS ALLERGEN DISC
K862938 · DHB
Immuno Nuclear Corp.
Immunology · 11d
Cleared Aug 15, 1986
ORCHARD GRASS ALLERGEN DISC
K862939 · DHB
Immuno Nuclear Corp.
Immunology · 11d