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

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176,076 results
80665–80688 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2001
CORTEX METAMAX
K001631 · BZC
Cortex Biophysik GmbH
Anesthesiology · 272d
Cleared Feb 22, 2001
MULTI-FUNCTION DEFIBRILLATION ELECTRODE
K002079 · MKJ
Medicotest A/S
Cardiovascular · 227d
Cleared Feb 22, 2001
MEDLOGICS ML 4000, MODEL 4000
K002515 · HNO
Med-Logics, Inc.
Ophthalmic · 191d
Cleared Feb 22, 2001
AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT...
K002758 · DSI
Agilent Technologies Deutschland GmbH
Cardiovascular · 170d
Cleared Feb 22, 2001
VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
K003260 · IPF
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 127d
Cleared Feb 22, 2001
Z-TOUCH
K003268 · HAW
Brainlab AG
Neurology · 127d
Cleared Feb 22, 2001
ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055
K003423 · FTD
St. Francis Medical Equipment Co., Ltd.
General & Plastic Surgery · 111d
Cleared Feb 22, 2001
MTP RESESURFACING JOINT-SMALL/9301-01
K003629 · KWD
Terray Corp.
Orthopedic · 90d
Cleared Feb 22, 2001
MINIENDO III
K003640 · ELB
Sybron Dental Specialties, Inc.
Dental · 87d
Cleared Feb 22, 2001
SUTUREGROOVE WEIGHT SIZING SET
K003646 · MML
Iop, Inc.
Ophthalmic · 87d
Cleared Feb 22, 2001
MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE
K003672 · IYO
Medge Platforms, Inc.
Radiology · 86d
Cleared Feb 22, 2001
TAUT-INSUFFLATION NEEDLE
K003703 · HIF
Taut, Inc.
Obstetrics & Gynecology · 83d
Cleared Feb 22, 2001
URETEROSCOPES
K003806 · FGB
Global Endoscopy, Inc.
Gastroenterology & Urology · 76d
Cleared Feb 22, 2001
CYSTOSCOPES
K003807 · FAJ
Global Endoscopy, Inc.
Gastroenterology & Urology · 76d
Cleared Feb 22, 2001
VISULAS YAG II
K003885 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 69d
Cleared Feb 22, 2001
MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
K003914 · GWG
Medtronic PS Medical
Neurology · 65d
Cleared Feb 22, 2001
ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP
K010007 · GCJ
Taut, Inc.
General & Plastic Surgery · 51d
Cleared Feb 22, 2001
ELECTRICATOR MODEL 26000
K010025 · GEI
Dermatologic Lab & Supply, Inc.
General & Plastic Surgery · 50d
Cleared Feb 22, 2001
HRH-127 HEAD ARRAY COIL
K010140 · MOS
Mri Devices Corp.
Radiology · 36d
Cleared Feb 22, 2001
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
K010214 · MKJ
Survivalink Corp.
Cardiovascular · 30d
Cleared Feb 21, 2001
PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
K001852 · DQK
Itamar Medical (C.M.) 1997 , Ltd.
Cardiovascular · 247d
Cleared Feb 21, 2001
ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING
K002896 · FRO
The Westaim Corp.
General & Plastic Surgery · 156d
Cleared Feb 21, 2001
VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073
K002912 · HIB
Sterinc
Obstetrics & Gynecology · 156d
Cleared Feb 21, 2001
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K003252 · LPN
Allergan, Inc.
Ophthalmic · 127d