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
110857–110880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1993
STEEROCATH II
K924109 · DRF
Ep Technologies, Inc.
Cardiovascular · 489d
Cleared Dec 16, 1993
516YT DISPLAY DRIVER
K926219 · DXJ
Vidco, Inc.
Cardiovascular · 371d
Cleared Dec 16, 1993
ATRIUM POLYPROPYLENE MESH
K930669 · FTL
Atrium Medical Corp.
General & Plastic Surgery · 308d
Cleared Dec 16, 1993
STERILIZATION WRAP-STERISHEET
K931202 · FRG
Arjo Wiggins Medical, Inc.
General Hospital · 282d
Cleared Dec 16, 1993
BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE
K931487 · CAI
Bird Life Design
Anesthesiology · 267d
Cleared Dec 16, 1993
XDCS-100
K932083 · DXT
Microwave Medical Systems, Inc.
Cardiovascular · 230d
Cleared Dec 16, 1993
CLASSIQUE
K932899 · KCZ
Hemispheres Marketing Co. , Ltd.
General & Plastic Surgery · 185d
Cleared Dec 16, 1993
BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE
K934084 · HMJ
Bioenterics Corp.
Ophthalmic · 118d
Cleared Dec 16, 1993
STERILE, DISPOSABLE ENDOSCOPIC TRUMPET VALVE
K934098 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 115d
Cleared Dec 16, 1993
TROCAR REDUCER WITH GAS CLHECK VALVE
K934185 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 112d
Cleared Dec 16, 1993
ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT...
K934602 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Dec 16, 1993
UVISOL AND UVISOL II
K934808 · FTC
National Biological Corp.
General & Plastic Surgery · 70d
Cleared Dec 16, 1993
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
K935136 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Dec 16, 1993
TOTAL PROTEIN TEST (TPRO)
K935174 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Dec 16, 1993
LACTATE DEHYDROGENASE (LD)
K935175 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Dec 16, 1993
IRON TEST
K935176 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Dec 16, 1993
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K935177 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Dec 16, 1993
LIFEPAK 9 DEFIBRILLATOR/MONITOR
K935674 · LDD
Physio-Control Corp.
Cardiovascular · 8d
Cleared Dec 15, 1993
CARAPACE STERILE CAST PADDING
K931672 · LGF
Carapace, Inc.
Orthopedic · 253d
Cleared Dec 15, 1993
MARTIN LEWIS WITH LINOCMYCIN
K931864 · JTY
Hardy Diagnostics
Microbiology · 245d
Cleared Dec 15, 1993
PYR TEST KIT
K931865 · JTO
Hardy Diagnostics
Microbiology · 245d
Cleared Dec 15, 1993
BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET
K932163 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 225d
Cleared Dec 15, 1993
CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE
K932259 · ERA
Clarus Medical Systems, Inc.
Ear, Nose, Throat · 239d
Cleared Dec 15, 1993
MODIFICATIONS TO INTRA-AORTIC BALLOONS
K932268 · DSP
Kontron Instruments, Inc.
Cardiovascular · 259d