FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93913–93936 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 1997
PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS
K971174 · HEB
Playtex, Inc.
Obstetrics & Gynecology · 51d
Cleared May 21, 1997
ACE HDL-C REAGENT
K971526 · LBS
Schiapparelli Biosystems, Inc.
Chemistry · 23d
Cleared May 21, 1997
SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL
K971534 · DIF
Beckman
Toxicology · 23d
Cleared May 20, 1997
SCOPETEX(TM)
K945590 · CCW
Smith Helms Mulliss & Moore, L.L.P.
Anesthesiology · 918d
Cleared May 20, 1997
UROSTYM
K962009 · KPI
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 363d
Cleared May 20, 1997
ULTRAFLEX DIAMOND
K962899 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 299d
Cleared May 20, 1997
ZOLL AUTOCLAVABLE INTERNAL HANDLES
K963781 · LDD
Zoll Medical Corp
Cardiovascular · 242d
Cleared May 20, 1997
EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
K964702 · MMQ
Euclid Systems Corp.
Ophthalmic · 176d
Cleared May 20, 1997
2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER
K964868 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 167d
Cleared May 20, 1997
RADIUS PTCA GUIDEWIRE
K970466 · LIT
Radius Medical Technologies, Inc.
Cardiovascular · 102d
Cleared May 20, 1997
OUR ROTATING GAMMA SYSTEM
K970647 · IWB
Our Scientific Intl., Inc.
Radiology · 89d
Cleared May 20, 1997
LOCKING STYLET 2
K970690 · DQX
Cook Pacemaker Corp.
Cardiovascular · 84d
Cleared May 20, 1997
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
K970873 · HMX
American Medical Devices, Inc.
Ophthalmic · 71d
Cleared May 20, 1997
ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)
K970875 · MPA
American Medical Devices, Inc.
Ophthalmic · 71d
Cleared May 20, 1997
HOWTEK 960
K970908 · LMA
Howtek, Inc.
Radiology · 70d
Cleared May 20, 1997
SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR
K970999 · JAK
Sony Medical Systems
Radiology · 62d
Cleared May 20, 1997
SAFE-T-CLAMP
K971277 · KNA
Talon Medical, Ltd.
Obstetrics & Gynecology · 43d
Cleared May 20, 1997
JEL-71 PDF
K971292 · EJT
J.F. Jelenko & Co., Inc.
Dental · 43d
Cleared May 20, 1997
VISTA SINGLE CHIP VIDEO CAMERA
K971373 · FET
Vista Medical Technologies, Inc.
Gastroenterology & Urology · 36d
Cleared May 20, 1997
UMI X-RAY FILM CASSETTE
K971431 · IXA
Umi Intl.
Radiology · 33d
Cleared May 20, 1997
PROSPORE
K971432 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 33d
Cleared May 20, 1997
CLARUS MODEL 5197 SIGHTLITE
K971455 · FTI
Clarus Medical Systems, Inc.
Gastroenterology & Urology · 29d
Cleared May 20, 1997
PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS...
K971515 · LPL
Biomed Devices Corp.
Ophthalmic · 25d
Cleared May 20, 1997
JELBOND-PDF
K971574 · EJT
J.F. Jelenko & Co., Inc.
Dental · 43d