Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
66793–66816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 2005
SELECT 3D ARTERIAL CANNULA
K043179 · DWF
Medtronic Perfusion Systems
Cardiovascular · 83d
Cleared Feb 08, 2005
C&G ACUPUNCTURE NEEDLE
K043277 · MQX
Helio Medical Supplies, Inc.
General Hospital · 74d
Cleared Feb 08, 2005
LIQUICHEK BNP CONTROL
K043584 · JJX
Bio-Rad Laboratories, Inc.
Chemistry · 42d
Cleared Feb 08, 2005
QUANTIX/OR BLOOD FLOW MONITOR
K050088 · DPW
Neoprobe Corp.
Cardiovascular · 26d
Cleared Feb 08, 2005
TINA-QUANT IGG GEN.2
K050113 · DEW
Roche Diagnostics Corp.
Immunology · 21d
Cleared Feb 08, 2005
EASY CORE BIOPSY SYSTEM II
K050120 · FCG
Boston Scientific Corp
Gastroenterology & Urology · 21d
Cleared Feb 08, 2005
CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE
K050167 · IYO
Chison Medical Imaging Co., Ltd.
Radiology · 13d
Cleared Feb 07, 2005
ATALIA TITANIUM SURGICAL MESH
K041798 · MQP
Us Spinal Technologies, LLC
Orthopedic · 220d
Cleared Feb 07, 2005
OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K042073 · KWQ
Olsen Medical
Orthopedic · 189d
Cleared Feb 07, 2005
QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121
K043051 · DJG
Phamatech, Inc.
Chemistry · 95d
Cleared Feb 07, 2005
NAVIGUS NEXDRIVE, MODEL MI-3000
K043091 · HAW
Image-Guided Neurologics, Inc.
Neurology · 90d
Cleared Feb 07, 2005
STEALTH FUSION SYSTEM, MODEL RR 1000
K043174 · KTT
R&R Medical, Inc.
Orthopedic · 83d
Cleared Feb 07, 2005
FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA
K043236 · HQF
Quantel Medical
Ophthalmic · 77d
Cleared Feb 07, 2005
RABEA SPINAL IMPLANT
K043316 · MQP
Signus Medizintechnik GmbH
Orthopedic · 67d
Cleared Feb 07, 2005
ONLINE DAT BENZODIAZEPINES PLUS
K043327 · JXM
Roche Diagnostics Corp.
Toxicology · 67d
Cleared Feb 07, 2005
VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM...
K043384 · LDO
Ortho-Clinical Diagnostics, Inc.
Chemistry · 60d
Cleared Feb 07, 2005
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE...
K043386 · LEH
Ortho-Clinical Diagnostics, Inc.
Toxicology · 60d
Cleared Feb 07, 2005
NUVASIVE COROENT SYSTEM
K043405 · MQP
Nuvasive, Inc.
Orthopedic · 59d
Cleared Feb 07, 2005
MEDTRONIC CLIP GUN KIT
K050044 · HBO
Medtronic Neurosurgery
Neurology · 28d
Cleared Feb 07, 2005
GEL MARK V
K050090 · NEU
Senorx, Inc.
General & Plastic Surgery · 24d
Cleared Feb 07, 2005
PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE
K050152 · LYY
Dipped Products (Thailand), Ltd.
General Hospital · 14d
Cleared Feb 07, 2005
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K050154 · LYZ
Zibo Zhuangyuan Plastic & Rubber Co.,...
General Hospital · 14d
Cleared Feb 07, 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K050155 · LYZ
Zibo Zhuangyuan Plastic & Rubber Co.,...
General Hospital · 14d
Cleared Feb 07, 2005
KATANA ZIRCONIA
K050160 · EIH
Noritake Co., Inc.
Dental · 13d