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
74857–74880 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2002
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K022434 · MND
C.R. Bard, Inc.
Gastroenterology & Urology · 11d
Cleared Aug 02, 2002
POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM
K012105 · KCT
Symmetry Medical, Inc.
General Hospital · 393d
Cleared Aug 02, 2002
BABY TEETHER, MODEL 20104
K014023 · KKO
Angelina Trading, Inc.
Dental · 239d
Cleared Aug 02, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON...
K020120 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 200d
Cleared Aug 02, 2002
CRC-15BT
K020150 · KPT
Capintec, Inc.
Radiology · 198d
Cleared Aug 02, 2002
BONESOURCE HAC
K021440 · GXP
Stryker Instruments
General & Plastic Surgery · 88d
Cleared Aug 02, 2002
RAPIDO GUIDING CATHETER, 6F MODEL# 6776
K021455 · DQY
Guidant Corp.
Cardiovascular · 88d
Cleared Aug 02, 2002
C.T.M. POWER CHAIR, MODEL HS-2800
K021617 · ITI
C.T.M. Homecare Product, Inc.
Physical Medicine · 78d
Cleared Aug 02, 2002
DISETRONIC D-TRON INSULIN INFUSION PUMP
K021725 · LZG
Disetronic Medical Systems AG
General Hospital · 70d
Cleared Aug 02, 2002
MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR
K022101 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 35d
Cleared Aug 02, 2002
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K022246 · FMF
Depuyacromed
General Hospital · 21d
Cleared Aug 02, 2002
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, &...
K022317 · LZG
Sooil Development Co., Ltd.
General Hospital · 16d
Cleared Aug 02, 2002
RELYX RMGIP
K022476 · EMA
3M Company
Dental · 4d
Cleared Aug 01, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K012687 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 352d
Cleared Aug 01, 2002
MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
K012693 · CBK
Acutronic Medical Systems AG
Anesthesiology · 352d
Cleared Aug 01, 2002
PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
K013093 · CAH
Pall Medical
General Hospital · 318d
Cleared Aug 01, 2002
LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
K020040 · LYY
Pt. Maja Agung Latexindo
General Hospital · 206d
Cleared Aug 01, 2002
NORMED BONE TRANSPORT DISTRACTION DEVICE
K021341 · JEY
Osteomedics, Inc.
Dental · 94d
Cleared Aug 01, 2002
NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
K021342 · JEY
Osteomedics, Inc.
Dental · 94d
Cleared Aug 01, 2002
DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS
K021352 · FIP
Dayton Water Systems
Gastroenterology & Urology · 94d
Cleared Aug 01, 2002
CLINPRO PROPHY POWDER
K021450 · KOJ
3M Espe AG Dental Products
Dental · 87d
Cleared Aug 01, 2002
STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL...
K021452 · LZA
Maxxim Medical
General Hospital · 87d
Cleared Aug 01, 2002
ER150/M2
K021456 · GCJ
World of Medicine Lemke GmbH
General & Plastic Surgery · 87d
Cleared Aug 01, 2002
FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL
K021457 · EBG
Pentron Corp.
Dental · 87d