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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
102937–102960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1995
BIOSTOP G BONE CEMENT RESTRICTOR
K943727 · LZN
Landos, Inc.
Orthopedic · 282d
Cleared May 11, 1995
BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER
K943797 · BZR
Bpr Medical, Ltd.
Anesthesiology · 281d
Cleared May 11, 1995
FUJI COMPUTED RADIOGRAPHY SYSTEMS
K944046 · IXW
Fujifilm Medical System U.S.A., Inc.
Radiology · 266d
Cleared May 11, 1995
ED CORP RADIATION SCREEN
K944445 · EAK
Med Corp.
Radiology · 241d
Cleared May 11, 1995
ETHICON DRILL BIT AND DRILL GUIDE
K944590 · HSZ
Ethicon, Inc.
Orthopedic · 234d
Cleared May 11, 1995
TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL
K945320 · ITX
Tetra Corp.
Radiology · 191d
Cleared May 11, 1995
LYFO(TM) DIFFERENTIAL DISK
K945487 · JSP
Microbiologics, Inc.
Microbiology · 184d
Cleared May 11, 1995
LYFO(TM) DIFFERENTIAL DISK
K945488 · JSP
Microbiologics, Inc.
Microbiology · 184d
Cleared May 11, 1995
LYFO(TM) DIFFERENTIAL DISK
K945489 · JSP
Microbiologics, Inc.
Microbiology · 184d
Cleared May 11, 1995
FST FIBEROPTIC PRESSURE CONVERTER
K945753 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 169d
Cleared May 11, 1995
THERMAFLEX, MODEL SD 55 C.P.M.H.
K945803 · JFA
Burke Neutech, Inc.
Physical Medicine · 164d
Cleared May 11, 1995
BIOSTIM-HV
K946298 · IPF
Progressive Concepts, Inc.
Physical Medicine · 135d
Cleared May 11, 1995
R 302
K946320 · KPW
Ralco S.R.L.
Radiology · 134d
Cleared May 11, 1995
KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS
K946359 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 132d
Cleared May 11, 1995
R-MED MINI-RETRACTOR
K950108 · HET
R-Med, Inc.
Obstetrics & Gynecology · 120d
Cleared May 11, 1995
B-D ULTRA-FINE II PEN NEEDLE
K950466 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 97d
Cleared May 11, 1995
COOK INSEMINATION CUP
K950714 · HDR
Cook Urological, Inc.
Obstetrics & Gynecology · 85d
Cleared May 11, 1995
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K950973 · LNH
GE Medical Systems
Radiology · 70d
Cleared May 11, 1995
KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR...
K950974 · FET
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 70d
Cleared May 11, 1995
KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR)...
K950975 · FET
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 70d
Cleared May 11, 1995
FAST FIND GRID
K950980 · KPR
Webb Research, Inc.
Radiology · 69d
Cleared May 11, 1995
CATHETERIZATION TABLE KS-60
K951315 · IZZ
Shimadzu Medical Systems
Radiology · 49d
Cleared May 11, 1995
AMSINO DISPOSABLE VIGINAL SPECULUM
K951528 · HIB
Amsino Intl., Inc.
Obstetrics & Gynecology · 38d
Cleared May 11, 1995
MED-TEC STRING RETICLE TRAY
K951601 · IWE
Medtec, Inc.
Radiology · 34d