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
70249–70272 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2003
CYNOSURE PHOTOGENICA SV LASER
K032539 · GEX
Cynosure, Inc.
General & Plastic Surgery · 91d
Cleared Nov 17, 2003
CAPROSYN ABSORBABLE SUTURE
K032586 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 87d
Cleared Nov 17, 2003
ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
K032987 · JHI
Unotech Diagnostics, Inc.
Chemistry · 54d
Cleared Nov 17, 2003
ORTHODEK
K033115 · GAM
Teleflex Medical
General & Plastic Surgery · 48d
Cleared Nov 17, 2003
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
K033134 · FGE
Ev3, Inc.
Gastroenterology & Urology · 48d
Cleared Nov 14, 2003
ACCUMAP AUTOMATIC PERIMETER
K022304 · GWE
Objectivision Pty , Ltd.
Neurology · 486d
Cleared Nov 14, 2003
SHILEY FLEXTRA TRACHEOSTOMY TUBE
K030787 · JOH
Nellcor Puritan Bennett, Inc.
Anesthesiology · 247d
Cleared Nov 14, 2003
BARD ENDOTRACHEAL TUBE, CUFFED
K030792 · BTR
C.R. Bard, Inc.
Anesthesiology · 247d
Cleared Nov 14, 2003
KWIKEZE MALE CONDOM APPLICATOR
K031007 · HIS
Condax, LLC
Obstetrics & Gynecology · 228d
Cleared Nov 14, 2003
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100
K031024 · BZH
Microlife Corp.
Anesthesiology · 228d
Cleared Nov 14, 2003
CLICK'X MONOAXIAL SCREWS AND HOOKS
K031175 · KWP
Synthes (Usa)
Orthopedic · 214d
Cleared Nov 14, 2003
AUTO-BAND LIGATOR
K031236 · MND
Scandimed. A.S.
Gastroenterology & Urology · 210d
Cleared Nov 14, 2003
OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR,...
K031380 · LCP
Olympus America, Inc.
Chemistry · 197d
Cleared Nov 14, 2003
SPIROPRO SPO2
K031515 · DQA
Viasys Healthcare GmbH
Anesthesiology · 184d
Cleared Nov 14, 2003
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
K031646 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 170d
Cleared Nov 14, 2003
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
K031965 · MHJ
Remel, Inc.
Microbiology · 141d
Cleared Nov 14, 2003
PASSMED SPINAL SYSTEM
K032094 · KWP
Medicrea
Orthopedic · 130d
Cleared Nov 14, 2003
BARD DUAL LUMEN URETERAL CATHETER
K032521 · EYB
C.R. Bard, Inc.
Gastroenterology & Urology · 91d
Cleared Nov 14, 2003
SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES
K032543 · EIA
Sirona Dental Systems GmbH
Dental · 88d
Cleared Nov 14, 2003
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV...
K032636 · HEB
Playtex Products, Inc.
Obstetrics & Gynecology · 79d
Cleared Nov 14, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA GREEN COLOR
K032670 · LYZ
Kingswell International, Inc.
General Hospital · 77d
Cleared Nov 14, 2003
MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE
K032777 · FOZ
Nipro Medical Corp.
General Hospital · 67d
Cleared Nov 14, 2003
PASCAL DYNAMIC CONTOUR TONOMETER
K032967 · HKY
Smt Swiss Microtechnology AG
Ophthalmic · 52d
Cleared Nov 14, 2003
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
K033007 · KXT
Bayer Diagnostics Corp.
Chemistry · 49d