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
120409–120432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1991
SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200
K911154 · FYD
Sun Medical, Inc.
General Hospital · 133d
Cleared Jul 26, 1991
SYSMEX F-610
K911172 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 149d
Cleared Jul 26, 1991
SYSMEX F-310
K911173 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 149d
Cleared Jul 26, 1991
PERRYMETER(TM)
K911190 · HIR
Perrymeter Systems
Gastroenterology & Urology · 130d
Cleared Jul 26, 1991
PLASTIC OVERLAYS
K911374 · HKW
National Reading Service
Ophthalmic · 120d
Cleared Jul 26, 1991
INSUL-LINE
K911443 · FPA
Trademark Corp.
General Hospital · 116d
Cleared Jul 26, 1991
THE NEEDLE NABBER
K911597 · FMI
J. Simmons Instrument , Ltd.
General Hospital · 108d
Cleared Jul 26, 1991
PRECISION OPTICS CORPORATION LAPAROSCOPE
K911744 · GCJ
Precise Optics
General & Plastic Surgery · 99d
Cleared Jul 26, 1991
ECONOVAGE R
K911788 · KDH
Autovage
Gastroenterology & Urology · 95d
Cleared Jul 26, 1991
MAJOLI UTERINE MANIPULATOR/INJECTOR
K911887 · LKF
Cook Ob/Gyn
Obstetrics & Gynecology · 88d
Cleared Jul 26, 1991
OSTEONICS(R) PRT HIP STEM SERIES
K911890 · JDI
Osteonics Corp.
Orthopedic · 88d
Cleared Jul 26, 1991
MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE
K911901 · ETF
Stortz
Ear, Nose, Throat · 88d
Cleared Jul 26, 1991
MODELS UES-10 & PSD-10
K911904 · GEI
Olympus Corp.
General & Plastic Surgery · 88d
Cleared Jul 26, 1991
MINIVAGE(R)
K911919 · KDH
Autovage
Gastroenterology & Urology · 87d
Cleared Jul 26, 1991
BONE NAIL, KUNTSCHER
K911982 · HSD
International Hospital Supply Co.
Orthopedic · 84d
Cleared Jul 26, 1991
MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM
K911998 · HQE
Allergan Medical Optics
Ophthalmic · 88d
Cleared Jul 26, 1991
ROBOTIC SAMPLE PROCESSOR
K912036 · JQW
Tecan U.S., Ltd.
Chemistry · 79d
Cleared Jul 26, 1991
ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS
K912048 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 78d
Cleared Jul 26, 1991
CEDIA(R) TOBRAMYCIN ASSAY
K912143 · LFW
Microgenics Corp.
Toxicology · 72d
Cleared Jul 26, 1991
URETERAL CATHETER HOLDER
K912146 · KNY
Inman Liebelt Corp.
Gastroenterology & Urology · 72d
Cleared Jul 26, 1991
COX DIAPOSABLE POLYPECTOMY SNARE
K912254 · FDI
Cox Medical Ent., Inc.
Gastroenterology & Urology · 66d
Cleared Jul 26, 1991
ARTEMA AQUA+
K912333 · BYD
Artema Medical AB
Anesthesiology · 63d
Cleared Jul 26, 1991
ARTEMA AQUA+ T & TS
K912334 · BYD
Artema Medical AB
Anesthesiology · 63d
Cleared Jul 26, 1991
ARTEMA AQUA+ N
K912335 · BYD
Artema Medical AB
Anesthesiology · 63d