FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
118201–118224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 1992
ECAT EXACT HR MODEL 961
K920624 · KPS
Cti Pet Systems, Inc.
Radiology · 76d
Cleared Apr 27, 1992
POLYTRON DIGITAL IMAGING SYSTEM
K920705 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 69d
Cleared Apr 27, 1992
KODAK X-OMAT FIXER MANAGER
K920715 · IXW
Eastman Kodak Company
Radiology · 69d
Cleared Apr 27, 1992
HIGH SPEED ROTATION STARTER SA-40
K920723 · ITY
Shimadzu Medical Systems
Radiology · 69d
Cleared Apr 27, 1992
HIGH SPEED ROTATION STARTER SA-50
K920724 · ITY
Shimadzu Medical Systems
Radiology · 69d
Cleared Apr 27, 1992
BUCKY TABLE BK-12
K920729 · IXQ
Shimadzu Medical Systems
Radiology · 69d
Cleared Apr 27, 1992
X-RAY HIGH VOLTAGE GENERATOR ED 125L
K920730 · IZO
Shimadzu Medical Systems
Radiology · 69d
Cleared Apr 27, 1992
HYDRAJUST IV UROLOGICAL TABLE
K920742 · IXR
Mallinckrodt Group, Inc.
Radiology · 68d
Cleared Apr 27, 1992
CARDIAC TRIAD NUCLEAR IMAGING SYSTEM
K920776 · KPS
Trionix Research Laboratory, Inc.
Radiology · 67d
Cleared Apr 27, 1992
QCC CUSTOM CANAL AND QE1 ALL ITE
K920911 · ESD
Qualitech Electronics, Inc.
Ear, Nose, Throat · 60d
Cleared Apr 27, 1992
PHILIPS EASYVISION
K920950 · LLZ
Philips Medical Systems, Inc.
Radiology · 61d
Cleared Apr 27, 1992
VECTOR SERIES
K921008 · KPS
Sopha Medical Systems, Inc.
Radiology · 55d
Cleared Apr 27, 1992
LOMEFLOXACIN, 10 MCG, SENSI DISC
K921193 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 46d
Cleared Apr 27, 1992
BARD 4-WIRE URETEROSCOPIC STONE
K921233 · FFL
C.R. Bard, Inc.
Gastroenterology & Urology · 45d
Cleared Apr 27, 1992
SONO-VU US(TM), MODIFICATION
K921738 · HIO
E-Z-Em, Inc.
Radiology · 89d
Cleared Apr 24, 1992
SLEEPMASTER
K911386 · BZQ
Biomedical Monitoring Systems, Inc.
Anesthesiology · 393d
Cleared Apr 24, 1992
DISPOSABLE ASPIRATION IRRIGATION SYSTEM
K912093 · HET
Applied Urology, Inc.
Obstetrics & Gynecology · 346d
Cleared Apr 24, 1992
INTRALUMINAL ARTERY STRIPPER
K913803 · DWX
Omni-Tract Surgical, Div. Minn....
Cardiovascular · 242d
Cleared Apr 24, 1992
URETEROMAT 4400
K915751 · EZN
F.M. Wiest USA, Inc.
Gastroenterology & Urology · 123d
Cleared Apr 24, 1992
IL TEST BARBITURATE, 35289
K920417 · DIS
Instrumentation Laboratory CO
Toxicology · 84d
Cleared Apr 24, 1992
IL TEST METHADONE
K920858 · DJR
Instrumentation Laboratory CO
Toxicology · 59d
Cleared Apr 24, 1992
PRESSURE GAUGE
K921026 · KNT
Hobbs Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Apr 23, 1992
AMETEC MASY MODULAR ANGIOSCOPE SYSTEM
K905745 · LYK
American Medical Technology, Inc.
Cardiovascular · 486d
Cleared Apr 23, 1992
SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT
K912070 · GEI
Siemens Medical Electronics
General & Plastic Surgery · 349d