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
108793–108816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 1994
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
K934847 · DTN
Sorin Biomedical, Inc.
Cardiovascular · 189d
Cleared Apr 15, 1994
KAPS POSITIONING ARM
K935381 · FWZ
Andronic Devices, Ltd.
General & Plastic Surgery · 158d
Cleared Apr 15, 1994
NEURON II AND MICROTENS
K935395 · GZJ
Datran Corp.
Neurology · 157d
Cleared Apr 15, 1994
GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM
K935757 · LBB
Greenleaf Medical Systems, Inc.
Neurology · 140d
Cleared Apr 15, 1994
BONE OR INTERFERENCE SCREW
K935836 · HWC
Endo Surgical Concepts, Inc.
Orthopedic · 129d
Cleared Apr 15, 1994
ONE STEP PREGNANCY TEST
K936031 · JHI
Teco Diagnostics
Chemistry · 119d
Cleared Apr 15, 1994
VIGIL PRX CHEMISTRY CONTROL
K936184 · JJY
Beckman-Diagnostic Systems Group
Toxicology · 109d
Cleared Apr 15, 1994
MEASURED VOLUME SOLUTION ADMINISTRATION SET
K940054 · FPA
Puritas Health Care, Inc.
General Hospital · 100d
Cleared Apr 15, 1994
MULTISET
K940055 · BRZ
Puritas Health Care, Inc.
General Hospital · 100d
Cleared Apr 15, 1994
SHAVER BLADE SET
K940075 · HRX
Arthrex, Inc.
Orthopedic · 99d
Cleared Apr 15, 1994
AUTO SYRINGE AS40A INFUSION PUMP
K940147 · FRN
Baxter Corp.
General Hospital · 94d
Cleared Apr 15, 1994
FORTE US
K940180 · IMG
Chattanooga Group, Inc.
Physical Medicine · 93d
Cleared Apr 15, 1994
OPTIBOND
K940513 · KLE
Kerr Corporation (Danbury)
Dental · 70d
Cleared Apr 15, 1994
MINTO SKIN TRACTION MOTOR
K940590 · ITH
Minto Research & Development, Inc.
Physical Medicine · 66d
Cleared Apr 15, 1994
AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER
K940678 · CAC
Baxter Healthcare Corp
Anesthesiology · 65d
Cleared Apr 15, 1994
STRYKER BACK-SAVER STRETCHER CHAIR MODEL 6320
K941088 · IOR
Stryker Corp.
Physical Medicine · 38d
Cleared Apr 15, 1994
HYGROBAC,S HYGROBOY AND HYGROBABY
K941381 · CAH
Mallinckrodt Medical
General Hospital · 24d
Cleared Apr 15, 1994
RETRACTOR
K941448 · GAD
Technovations
General & Plastic Surgery · 22d
Cleared Apr 15, 1994
TRACHEOLIFE
K941535 · BYD
Mallinckrodt Medical
Anesthesiology · 16d
Cleared Apr 14, 1994
BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
K922527 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 686d
Cleared Apr 14, 1994
MEDICOM NON-WOVEN SPONGES
K935257 · EFQ
A.R. Medicom, Inc.
General & Plastic Surgery · 164d
Cleared Apr 14, 1994
STORZ N5941 SERIES MEDICAL GRADE TUBING
K940352 · GBX
Storz Instrument Co.
General & Plastic Surgery · 79d
Cleared Apr 14, 1994
TELETOM
K940405 · KMI
Berchtold Holding GmbH
General Hospital · 77d
Cleared Apr 14, 1994
PLAIN GAUZE DRESSING
K940692 · EFQ
Medtrax Industries, Inc.
General & Plastic Surgery · 57d