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
115609–115632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1992
LA MONT VIDEO PATIENT MONITORING SYSTEM
K921485 · GWQ
Medical Systems Corp.
Neurology · 206d
Cleared Oct 22, 1992
INFANT STAR SERIES 500
K923704 · CBK
Infrasonics Corp.
Anesthesiology · 90d
Cleared Oct 22, 1992
PARAMETRIC PROCESS CONTROL
K923826 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 84d
Cleared Oct 22, 1992
NOISE REDUCTION UNIT W/ LAST IMAGE HOLD
K923913 · LLZ
Jms Imaging Products, Inc.
Radiology · 79d
Cleared Oct 22, 1992
ROCHE REAGENT FOR ALT
K924245 · CKA
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Oct 21, 1992
MODIFICATIONS TO SERIES OF CARDIAC CATHETERS
K913042 · DXO
Sentron, Inc.
Cardiovascular · 484d
Cleared Oct 21, 1992
Q FEVER IGG IFA TEST
K913906 · GPJ
Hillcrest Biologicals
Microbiology · 418d
Cleared Oct 21, 1992
3M LITTMANN GRAPHIC DISPLAY SYSTEM
K920009 · DQD
3M Health Care, Ltd.
Cardiovascular · 293d
Cleared Oct 21, 1992
BIOPSY FORCEPS
K921401 · DWZ
Annex Medical, Inc.
Cardiovascular · 211d
Cleared Oct 21, 1992
INTERP-1000
K921476 · LOS
Qmed, Inc.
Cardiovascular · 205d
Cleared Oct 21, 1992
Q FEVER IGM IFA TEST
K922374 · GPJ
Hillcrest Biologicals
Microbiology · 154d
Cleared Oct 21, 1992
FAMILY EAR SCOPE MODEL 29001S
K923304 · ERA
Ear Care of So. Ca., Inc.
Ear, Nose, Throat · 107d
Cleared Oct 21, 1992
DIGITAL FLUORO STORE
K923585 · JAA
Eigen
Radiology · 93d
Cleared Oct 21, 1992
A BREAST COIL FOR THE GYREX 2T-DIX
K923897 · LNH
Elscint, Inc.
Radiology · 78d
Cleared Oct 21, 1992
ELECTROCARDIOGRAPH TRANSMITTER
K923930 · DXH
Tz Medical, Inc.
Cardiovascular · 77d
Cleared Oct 20, 1992
GE SONOCHROME
K915138 · MAA
GE Medical Systems
Radiology · 342d
Cleared Oct 20, 1992
PORTABLE LIMB LOAD MONITOR (BMLLM-100)
K915326 · IKE
Bar Med Pty , Ltd.
Physical Medicine · 333d
Cleared Oct 20, 1992
OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD
K915396 · LZO
Osteonics Corp.
Orthopedic · 326d
Cleared Oct 20, 1992
LESTER PRESS FIT HIP PROSTHESIS
K915500 · JDI
Kirschner Medical Corp.
Orthopedic · 316d
Cleared Oct 20, 1992
SHARPE ENDOHEMOSTAT
K915744 · HET
Paladin Medical, Inc.
Obstetrics & Gynecology · 302d
Cleared Oct 20, 1992
SHARPE ENDOFORCEPS
K915747 · HET
Paladin Medical, Inc.
Obstetrics & Gynecology · 302d
Cleared Oct 20, 1992
SHARPE ENDOLIGATURE CARRIER
K915749 · HET
Paladin Medical, Inc.
Obstetrics & Gynecology · 302d
Cleared Oct 20, 1992
SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI
K920319 · LLZ
Siemens Gammasonics, Inc.
Radiology · 270d
Cleared Oct 20, 1992
CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM
K921192 · JAK
GE Medical Systems
Radiology · 222d