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
92473–92496 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 1997
LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION...
K972958 · GCJ
Lysonix, Inc.
General & Plastic Surgery · 39d
Cleared Sep 19, 1997
SILICONE BILIARY STENT/BILIARY CATHETER
K973114 · FGE
Specialty Surgical Products, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 18, 1997
SEAGER ELECTROEJACULATOR
K962379 · LNL
National Rehab Hospital
Gastroenterology & Urology · 455d
Cleared Sep 18, 1997
ONE-WAY VALVE (WITH CONNECTOR)
K970780 · CBP
Instrumentation Industries, Inc.
Anesthesiology · 198d
Cleared Sep 18, 1997
LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP
K971543 · HGX
Kaweco GmbH
Obstetrics & Gynecology · 143d
Cleared Sep 18, 1997
MODEL 20 BIPOLAR COAGULATOR
K972311 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 90d
Cleared Sep 18, 1997
MONTGOMERY THYROPLASTY IMPLANT SYSTEM
K972317 · MIX
Boston Medical Products, Inc.
Ear, Nose, Throat · 90d
Cleared Sep 18, 1997
SILENTNITE
K972424 · LRK
Glidewell Laboratories
Dental · 83d
Cleared Sep 18, 1997
NIPRO DISPOSABLE SOLUTION INFUSION SET
K972493 · FPA
Nipro Medical Corp.
General Hospital · 77d
Cleared Sep 18, 1997
RESUABLE HOT BIOPSY FORCEPS
K972505 · KGE
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 77d
Cleared Sep 18, 1997
PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS
K972527 · FPA
Quality System Consulting
General Hospital · 73d
Cleared Sep 18, 1997
S-357 VIDEO IMAGING SYSTEM
K972540 · FET
Sopro
Gastroenterology & Urology · 73d
Cleared Sep 18, 1997
AURELUX BIO Y85PF
K972949 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 90d
Cleared Sep 18, 1997
PROSTATE SPECIFIC ANTIGEN METHOD
K973101 · LTJ
Dade Chemistry Systems, Inc.
Immunology · 30d
Cleared Sep 17, 1997
MICROETCHER AP
K970589 · KOJ
Danville Engineering, Inc.
Dental · 211d
Cleared Sep 17, 1997
GLUCOSITE TEST SYSTEM
K971145 · CGA
Gds Technology, LLC
Chemistry · 173d
Cleared Sep 17, 1997
RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE
K971508 · KIR
Bio-Whittaker, Inc., A Cambrex Co.
Microbiology · 145d
Cleared Sep 17, 1997
SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT
K972283 · BTM
Sims
Anesthesiology · 90d
Cleared Sep 17, 1997
ACS HI-TORQUE RULER GUIDE WIRE
K972290 · DQX
Guidant Corp.
Cardiovascular · 90d
Cleared Sep 17, 1997
BIG BEN SQUARE, BIG BEN ROUND
K972301 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Sep 17, 1997
THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM
K972417 · DZE
Bicon, Inc.
Dental · 82d
Cleared Sep 17, 1997
IPS EMPRESS COSMO INGOT
K972827 · EIH
Ivoclar North America, Inc.
Dental · 49d
Cleared Sep 17, 1997
SUNGLASSES
K972850 · HQY
Indoptica, S.A.
Ophthalmic · 47d
Cleared Sep 17, 1997
COSMOPOST
K972875 · ELR
Ivoclar North America, Inc.
Dental · 44d