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
152281–152304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 1984
CPR LOCATOR
K833737 · LIX
Lifepoint,Inc
Cardiovascular · 304d
Cleared Aug 24, 1984
CLINI-TEK AUTO 2000 REFLECTANCE SPECTR
K841041 · KQO
Miles Laboratories, Inc.
Chemistry · 165d
Cleared Aug 24, 1984
BP800, 850 1000
K841095 · DXN
Associated Mills, Inc.
Cardiovascular · 164d
Cleared Aug 24, 1984
MICRO FLUID APPLICATOR
K841357 · JZF
Treace Medical, Inc.
Ear, Nose, Throat · 144d
Cleared Aug 24, 1984
INTERMITTENT URETHRAL CATHETER TRAY
K841769 · KOD
Seamless Hospital Products Co.
Gastroenterology & Urology · 116d
Cleared Aug 24, 1984
CUSTOM STERILE PROCEDURE TRAYS-MULTI
K841850
Sterilco, Inc.
General & Plastic Surgery · 113d
Cleared Aug 24, 1984
PICKER ARTIS ULTRASOUND IMAGING SYS
K842055 · IYN
Philips Medical Systems (Cleveland),...
Radiology · 94d
Cleared Aug 24, 1984
ACU-DERM TRANSPARENT WOUND DRESSING
K842186 · NAD
Acme United Corp.
General & Plastic Surgery · 84d
Cleared Aug 24, 1984
DUOCLON COLOR-CEPT
K842314 · JHJ
Organon, Inc.
Chemistry · 73d
Cleared Aug 24, 1984
ELECTRONIC DIGITAL BP METER HC 3001
K842486 · DXN
North American Philips Corp.
Cardiovascular · 59d
Cleared Aug 24, 1984
ACCESSORY FOR ADULT VOL. VENTILATOR
K842580 · CAH
Infrasonics Corp.
General Hospital · 52d
Cleared Aug 24, 1984
RIONET HEARING AID HB-35
K842875 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 32d
Cleared Aug 24, 1984
BIAS TOTAL HIP
K842906 · JDI
Zimmer, Inc.
Orthopedic · 31d
Cleared Aug 24, 1984
540 CAPNOGRAPH
K842978 · CCK
Spacelabs, Inc.
Anesthesiology · 25d
Cleared Aug 24, 1984
BP-1000
K843009 · DXN
Pollenex Associated Mills, Inc.
Cardiovascular · 23d
Cleared Aug 24, 1984
KERR COMMAND ULTRAFINE POLISHING PASTE
K843022 · EJR
Kerr Corporation (Danbury)
Dental · 23d
Cleared Aug 24, 1984
TAMBRANDS INC. ILL.P. 2
K843061 · HHD
Tambrands, Inc.
Obstetrics & Gynecology · 21d
Cleared Aug 24, 1984
ESOPHAGEAL STETHOSCOPES
K843070 · BZW
Primrose Medical, Inc.
Anesthesiology · 18d
Cleared Aug 24, 1984
ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR
K843071 · BZT
Primrose Medical, Inc.
Anesthesiology · 18d
Cleared Aug 24, 1984
FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP
K843073 · JQW
Greene International Corp.
Chemistry · 18d
Cleared Aug 24, 1984
SURE & NATURAL DEODORANT MAXI-SHIELD
K843155 · HHL
Johnson & Johnson Professionals, Inc.
Obstetrics & Gynecology · 14d
Cleared Aug 24, 1984
QUALINE WHEELCHAIR PRODUCTS
K843213 · IQC
Contemporary Health Sys
Physical Medicine · 9d
Cleared Aug 24, 1984
MEGASON MODEL 150
K843221 · IMI
Birtcher Corp.
Physical Medicine · 8d
Cleared Aug 23, 1984
TX-2 THERMAL DILUTION CARDIAC OUTPUT
K834408 · DXG
Waters Instruments, Inc.
Cardiovascular · 253d