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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
120673–120696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1991
KITS AND TRAYS FOR ONE TIME USE ONLY
K903963 · LRP
Apk Technology
General & Plastic Surgery · 335d
Cleared Jul 29, 1991
BRONCHOSCOPE ACCESSORY, NSN 6515-00-315-2200
K911922 · EOQ
Delta Industries, Inc.
Ear, Nose, Throat · 90d
Cleared Jul 26, 1991
ADVANCE SUTURE NONABSORBABLE DACRON SUTURE
K903175 · GAS
Advance Suture, Inc.
General & Plastic Surgery · 373d
Cleared Jul 26, 1991
FORCEPS
K904723 · GEN
Minto Research & Development, Inc.
General & Plastic Surgery · 282d
Cleared Jul 26, 1991
GROSS HIP FEMORAL COMPONENT
K904737 · JDI
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 281d
Cleared Jul 26, 1991
INTAVENT LARYNGEAL MASK
K904834 · CAE
Intavent Intl. S.A.
Anesthesiology · 275d
Cleared Jul 26, 1991
RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
K910304 · LQL
Vitek Systems, Inc.
Microbiology · 183d
Cleared Jul 26, 1991
ULTIMATE 3000
K910839 · LNH
Fonar Corp.
Radiology · 149d
Cleared Jul 26, 1991
SYSMEX F-810
K910849 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 149d
Cleared Jul 26, 1991
FINN KNEE PROSTHESIS
K910877 · KRO
Biomet, Inc.
Orthopedic · 147d
Cleared Jul 26, 1991
MASTERPIECES MICRO SYSTEM
K910957 · HRS
Storz Instrument Co.
Orthopedic · 142d
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