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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
31417–31440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2016
PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove
K153678 · FRO
Permeaderm, Inc.
General & Plastic Surgery · 231d
Cleared Aug 08, 2016
Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G...
K153709 · KNW
Devicor Medical Products, Inc.
Gastroenterology & Urology · 229d
Cleared Aug 08, 2016
Apollo Balloon Dilatation Catheter
K153742 · LOX
Brosmed Medical Co., Ltd.
Cardiovascular · 224d
Cleared Aug 08, 2016
P-ARTIS
K160611 · JAK
P-Cure, Ltd.
Radiology · 158d
Cleared Aug 08, 2016
WoundClot9
K160679 · QSY
Core Scientific Creation , Ltd.
General & Plastic Surgery · 151d
Cleared Aug 08, 2016
Philips Ingenuity CT
K160743 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 144d
Cleared Aug 08, 2016
Cerafix Dura Substitute
K161278 · GXQ
Acera Surgical, Inc.
Neurology · 94d
Cleared Aug 08, 2016
BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a...
K161306 · MDB
Becton Dickinson
Microbiology · 90d
Cleared Aug 07, 2016
da Vinci Xi Surgical System
K153276 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 269d
Cleared Aug 07, 2016
Steerable Guide Catheter
K161985 · DRA
Abbott Vascular
Cardiovascular · 19d
Cleared Aug 05, 2016
Image Fast Set, Image Regular Set
K160097 · ELW
Sybron Dental Specialties
Dental · 199d
Cleared Aug 05, 2016
ArgenIS Titanium Abutments
K160248 · NHA
Argen Corporation
Dental · 186d
Cleared Aug 05, 2016
Triton System
K160338 · PBZ
Gauss Surgical, Inc.,
General & Plastic Surgery · 179d
Cleared Aug 05, 2016
Burn-out Cylinder and Angled Screw Abutments
K160483 · NHA
Dentium Co., Ltd.
Dental · 165d
Cleared Aug 05, 2016
Verza Guidance System
K160806 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 134d
Cleared Aug 05, 2016
Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors...
K160865 · DQA
Nonin Medical, Inc.
Anesthesiology · 128d
Cleared Aug 05, 2016
QXLink
K161113 · LLZ
Vieworks Co., Ltd.
Radiology · 107d
Cleared Aug 05, 2016
LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3
K161224 · IYN
GE Medical Systems Ultrasound &...
Radiology · 98d
Cleared Aug 05, 2016
EP-TRACER System
K161245 · DQK
Cardio Tek, BV
Cardiovascular · 94d
Cleared Aug 05, 2016
SYSTEM 1E Liquid Chemical Sterilant Processing System
K161683 · MED
STERIS Corporation
General Hospital · 49d
Cleared Aug 05, 2016
Vivid iq
K161706 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 46d
Cleared Aug 05, 2016
On Call Pro Blood Glucose Monitoring System
K161867 · NBW
Acon Laboratories
Chemistry · 29d
Cleared Aug 05, 2016
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator...
K161877 · HEB
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 28d
Cleared Aug 04, 2016
CAPO BULK FILL
K152471 · EBF
Schuetz Dental GmbH
Dental · 339d