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
49873–49896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2010
POWDERED VINYL PATIENT EXAMINATION GLOVES
K101664 · LYZ
Hebei Excellent Plastic Co., Ltd.
General Hospital · 43d
Cleared Jul 26, 2010
MED-SEG, MODEL BTMS 1000
K092328 · LLZ
Bartron Medical Imaging, Inc.
Radiology · 356d
Cleared Jul 26, 2010
THE PANPAC SUCTION CURETTE
K092982 · HHK
Panpac Medical Corporation
Obstetrics & Gynecology · 301d
Cleared Jul 26, 2010
PHILIPS OBTRACEVUE MODEL SW REV. G.00
K100420 · HGM
Philips Medizin Systeme Boeblingen GmbH
Obstetrics & Gynecology · 160d
Cleared Jul 26, 2010
SYNAPSE 3D BASIC TOOLS
K101662 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 42d
Cleared Jul 23, 2010
THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
K091939 · HIG
Thermedx, LLC
Obstetrics & Gynecology · 388d
Cleared Jul 23, 2010
DEFCON TSA/TSH DENTAL IMPLANT SYSTEM
K092261 · DZE
Impladent, S.L.
Dental · 360d
Cleared Jul 23, 2010
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE,...
K100133 · MWI
Airstrip Technologies, LP
Cardiovascular · 185d
Cleared Jul 23, 2010
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
K100147 · NKB
Aesculap Implant System, Inc.
Orthopedic · 185d
Cleared Jul 23, 2010
DETAX IMPLANTLINK SEMI
K100247 · EMA
Detax GmbH & Co. KG
Dental · 177d
Cleared Jul 23, 2010
MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01
K100543 · GEI
Medisiss
General & Plastic Surgery · 148d
Cleared Jul 23, 2010
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
K100682 · JLX
Wallac OY
Chemistry · 135d
Cleared Jul 23, 2010
QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB
K100813 · DPS
Pulse Biomedical, Inc.
Cardiovascular · 122d
Cleared Jul 23, 2010
REPROCESSED COMPRESSION SLEEVES
K100909 · JOW
Ascent Healthcare Solutions
Cardiovascular · 113d
Cleared Jul 23, 2010
MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES
K100958 · HAE
Baxano, Inc.
Neurology · 107d
Cleared Jul 23, 2010
MINI-TONG
K101101 · OCW
Mini Lap Technologies, Inc.
Gastroenterology & Urology · 94d
Cleared Jul 23, 2010
PRO-TOE VO HAMMERTOW IMPLANT SYSTEM
K101165 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Jul 23, 2010
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM
K101206 · HSX
Alexandria Research Technologies, LLC
Orthopedic · 84d
Cleared Jul 23, 2010
GUARDIAN CONNECTION
K101214 · FPD
Maulin Medical, LLC
Gastroenterology & Urology · 84d
Cleared Jul 23, 2010
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22
K101240 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 80d
Cleared Jul 23, 2010
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
K101314 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 73d
Cleared Jul 23, 2010
SCOUTPRO ACS
K101776 · DQY
Biotronik, Inc.
Cardiovascular · 28d
Cleared Jul 23, 2010
PIONEER PLUS CATHETER, MODEL PLUS 120
K101777 · PDU
Medtronic Vascular
Cardiovascular · 28d
Cleared Jul 23, 2010
ADVANIX DOUBLE PIGTAIL BILIARY STENT
K101786 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 28d