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
95305–95328 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 1997
KSEA PUNCTURE CANNULA
K964379 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 86d
Cleared Jan 29, 1997
SUNGLASSES
K964564 · HQY
Micron Metal & Plastic Manufactory Co.
Ophthalmic · 76d
Cleared Jan 29, 1997
SENNA
K964744 · HQY
Trans-America Enterprises Corp.
Ophthalmic · 64d
Cleared Jan 28, 1997
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY...
K962689 · CAC
Cobe Cardiovascular, Inc.
Anesthesiology · 201d
Cleared Jan 28, 1997
SOF. PRESS EPC 51 SYSTEM
K963067 · JOW
Gaymar Industries, Inc.
Cardiovascular · 174d
Cleared Jan 28, 1997
TORQUE DEVICE
K964352 · DQX
B.Braun Medical, Inc.
Cardiovascular · 88d
Cleared Jan 28, 1997
DALE ENDOTRACHEAL TUBE HOLDER 270/280
K964399 · CBH
Dale Medical Products, Inc.
Anesthesiology · 85d
Cleared Jan 28, 1997
TRANSEND GUIDEWIRE
K964611 · DQX
Boston Scientific Corp
Cardiovascular · 71d
Cleared Jan 28, 1997
EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM
K964919 · HRX
Emerald Medical, Inc.
Orthopedic · 50d
Cleared Jan 28, 1997
VIDAMED MODEDL 7600 RF GENERATOR
K965061 · GEI
Vidamed, Inc.
General & Plastic Surgery · 41d
Cleared Jan 28, 1997
DILATION CATHETER, BALLOON
K965067 · GBM
Boston Scientific Corp
Gastroenterology & Urology · 41d
Cleared Jan 28, 1997
SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES
K970056 · GCJ
Woodbine Optical Corp.
General & Plastic Surgery · 21d
Cleared Jan 27, 1997
ECLIPSE 2000
K961560 · GEX
Cardiogenes
General & Plastic Surgery · 291d
Cleared Jan 27, 1997
COMPLEAT SURGICAL MASK
K962654 · FXX
Carl Parker Associates, Inc.
General Hospital · 203d
Cleared Jan 27, 1997
ANEROID AND MERCURIAL SPHYGMOMANOMETERS
K962655 · DXQ
American Diagnostic Corp.
Cardiovascular · 203d
Cleared Jan 27, 1997
HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO...
K962854 · LOS
Cardio Control BV
Cardiovascular · 189d
Cleared Jan 27, 1997
GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON
K963509 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 146d
Cleared Jan 27, 1997
THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE
K963675 · KKX
Micro-Medical Devices, Inc.
General Hospital · 136d
Cleared Jan 27, 1997
JOBST ATHROMBIC PUMP SYSTEM 2100
K963929 · JOW
Jobst A Beiersdorf Co.
Cardiovascular · 144d
Cleared Jan 27, 1997
OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)
K963946 · LPH
Osteonics Corp.
Orthopedic · 117d
Cleared Jan 27, 1997
METAL BACKED ACETABULAR COMPONENT
K963998 · LPH
Encore Orthopedics, Inc.
Orthopedic · 112d
Cleared Jan 27, 1997
DG NERVUS
K964280 · GWQ
Medelec , Ltd.
Neurology · 91d
Cleared Jan 27, 1997
NATURAL-HIP SYSTEM COCR STEM
K964357 · LZO
Intermedics Orthopedics
Orthopedic · 87d
Cleared Jan 27, 1997
MODEL D-290P ADMINISTRATION SET
K964384 · FPA
Patient Solutions, Inc.
General Hospital · 84d