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
97513–97536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1996
ASEPTYLUM, UNI-CARRIER
K961714 · EKJ
Distriflor S.A.
Dental · 39d
Cleared Jun 10, 1996
ELECTRONIC THERMOMETER
K961879 · FLL
Wiltec Industries , Ltd.
General Hospital · 26d
Cleared Jun 07, 1996
MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
K951709 · LSR
Mardx Diagnostics, Inc.
Microbiology · 421d
Cleared Jun 07, 1996
CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951821 · LIN
Light Diagnostics
Microbiology · 414d
Cleared Jun 07, 1996
SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960)
K952054 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 403d
Cleared Jun 07, 1996
CLS STEM (MODIFICATION)
K953690 · LZO
Intermedics Orthopedics
Orthopedic · 312d
Cleared Jun 07, 1996
SHIELDED TROCAR (OBTURATOR)
K954774 · HET
Gabris Surgical Corp.
Obstetrics & Gynecology · 234d
Cleared Jun 07, 1996
OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER
K955059 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 214d
Cleared Jun 07, 1996
HEARTPORT ENDOAORTIC CLAMP
K955132 · DXC
Heartport, Inc.
Cardiovascular · 211d
Cleared Jun 07, 1996
LMD CRYPTOSPORIDIUM ANTIGEN DETECTION
K955345 · MHJ
Lmd Laboratories
Microbiology · 199d
Cleared Jun 07, 1996
PROTEK LOW PROFILE ACETABULAR CUP
K960025 · JDI
Intermedics Orthopedics
Orthopedic · 157d
Cleared Jun 07, 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT...
K960183 · LYR
Smithkline Diagnostics, Inc.
Microbiology · 143d
Cleared Jun 07, 1996
KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY
K960981 · LMB
Kodak Health Imaging Systems, Inc.
Radiology · 88d
Cleared Jun 07, 1996
1.2MM REUSABLE NEUROVIEW ENDOSCOPE
K961173 · GWG
Neuro Navigational Corp.
Neurology · 74d
Cleared Jun 07, 1996
ASPIRATION/IRRIGATION CATHETER
K961300 · GWG
Neuro Navigational Corp.
Neurology · 64d
Cleared Jun 07, 1996
MEDI-TRACE RADIOLUCENT
K961395 · DRX
Graphic Controls Corp.
Cardiovascular · 57d
Cleared Jun 07, 1996
FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS
K961623 · GKZ
Becton Dickinson Monoclonal Center
Hematology · 42d
Cleared Jun 06, 1996
HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND
K954131 · ITI
Hoveround Corp.
Physical Medicine · 279d
Cleared Jun 06, 1996
FIRARD II/ TDP LAMP
K960036 · ILY
Helio Medical Supplies, Inc.
Physical Medicine · 156d
Cleared Jun 06, 1996
DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS
K960704 · HWC
Depuy, Inc.
Orthopedic · 118d
Cleared Jun 06, 1996
UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)
K961051 · JWJ
Kinetikos Medical, Inc.
Orthopedic · 87d
Cleared Jun 06, 1996
BIOVIEW MODEL S960000
K961056 · KLA
Sandhill Scientific, Inc.
Gastroenterology & Urology · 80d
Cleared Jun 06, 1996
CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)
K961061 · EFQ
Codi International BV
General & Plastic Surgery · 80d
Cleared Jun 06, 1996
BAXTER SODIUM ACETATE INFANT HEEL WARMER
K961154 · MPO
Baxter Healthcare Corp
Physical Medicine · 76d