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
98137–98160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 1996
AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER
K945957 · IYN
Kleinfeld, Kaplan and Becker
Radiology · 496d
Cleared Apr 15, 1996
REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A
K950972 · JAK
Toshiba America Medical Systems, In.C
Radiology · 410d
Cleared Apr 15, 1996
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
K951359 · LFX
Bayer Corp.
Microbiology · 385d
Cleared Apr 15, 1996
OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER
K951994 · IYO
Olympus America, Inc.
Radiology · 353d
Cleared Apr 15, 1996
PLATINUM SERIES EP DIAGNOSTIC CATHETERS
K953185 · DRF
Medtronic Cardiorhythm
Cardiovascular · 280d
Cleared Apr 15, 1996
INNOVA RECTAL STIMULATON ELECTRODE
K954272 · KPI
Empi
Gastroenterology & Urology · 216d
Cleared Apr 15, 1996
POWERS ANTI-BACTERIAL VALVE
K954471 · EIA
Powers Dental & Medical Technology, Inc.
Dental · 202d
Cleared Apr 15, 1996
ENTERALITE
K954735 · LZH
Zevex Intl., Inc.
General Hospital · 182d
Cleared Apr 15, 1996
D.O.R.C. VFI/VFE SYSTEM
K954842 · KYG
Dutch Ophthalmic USA, Inc.
Ophthalmic · 175d
Cleared Apr 15, 1996
GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES
K954967 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 168d
Cleared Apr 15, 1996
CARDS Q.S. STREP A
K955108 · GTZ
Quidel Corp.
Microbiology · 159d
Cleared Apr 15, 1996
DENTO-SURGE
K955176 · EKZ
Ellman Intl., Inc.
Dental · 154d
Cleared Apr 15, 1996
POWDER FREE TACTYLON SURGEONS GLOVE
K955419 · KGO
Tactyl Technologies, Inc.
General Hospital · 140d
Cleared Apr 15, 1996
G.E. STERILE CT BIOPSY TRAY
K960144 · DWS
GE Medical Systems
Cardiovascular · 90d
Cleared Apr 15, 1996
CARBOMEDICS VALVE TESTER
K960169 · DTJ
Carbomedics, Inc.
Cardiovascular · 90d
Cleared Apr 15, 1996
THYROCHEK ONE-STEP RAPID TSH ASSAY
K960195 · JLW
Franklin Diagnostics, Inc.
Chemistry · 90d
Cleared Apr 15, 1996
CPR SUCTION CATHETER KIT
K960216 · JOL
Custom Pack Reliability
General Hospital · 90d
Cleared Apr 15, 1996
CORING MORCELLATOR
K960262 · HET
Cook Urological, Inc.
Obstetrics & Gynecology · 88d
Cleared Apr 15, 1996
GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS
K960292 · NPK
W.L. Gore & Associates, Inc.
Dental · 84d
Cleared Apr 15, 1996
THERAPORT VASCULAR ACCESS SYSTEM
K960350 · LJT
Biocontrol Technology, Inc.
General Hospital · 81d
Cleared Apr 15, 1996
Q-LUX LIGHT CURE UNIT
K960351 · EBZ
Rolence Enterprise Co. , Ltd.
Dental · 81d
Cleared Apr 15, 1996
PERMAMESH-D HYDROXYLAPATITE MATRIX
K960361 · LYC
Ceramed Corp.
Dental · 81d
Cleared Apr 15, 1996
CU-200 LIGHT CURE UNIT
K960364 · EBZ
Rolence Enterprise Co. , Ltd.
Dental · 81d
Cleared Apr 15, 1996
TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION)
K960514 · JEY
Anspach Fixation Systems
Dental · 81d