FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
151441–151464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 23, 1984
DOPPLER IMAGING OPTION
K840140 · IYN
Hewlett-Packard Co.
Radiology · 232d
Cleared Aug 23, 1984
BETA SCAN DRYSTIX
K841369 · CGA
Orange Medical Instruments, Inc.
Chemistry · 142d
Cleared Aug 23, 1984
EARETTE HEARING AID OTICON E31V
K842073 · ESD
Oticon Corp.
Ear, Nose, Throat · 92d
Cleared Aug 23, 1984
EARETTE HEARING AID OTICON E30V
K842074 · ESD
Oticon Corp.
Ear, Nose, Throat · 92d
Cleared Aug 23, 1984
AUGMENTIN 30 MCG SENSI DISC
K842253 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 77d
Cleared Aug 23, 1984
BEHING THE EAR HEARING AID T-98
K842434 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 64d