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

Filters: Cleared only ×
175,820 results
36457–36480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 2014
SYNGO.CT COLONOGRAPHY
K140920 · NWE
Siemens Medical Solutions USA, Inc.
Radiology · 237d
Cleared Dec 03, 2014
INMODE WMFACE DEVICE
K140926 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 236d
Cleared Dec 03, 2014
SURVEYOR S4 MOBILE MONITOR
K141020 · DRG
Mortara Instrument, Inc.
Cardiovascular · 226d
Cleared Dec 03, 2014
WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141279 · LZA
Wanghui Glove Co., Ltd.
General Hospital · 201d
Cleared Dec 03, 2014
HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR
K141287 · LZA
Huikang Glove Co., Ltd.
General Hospital · 201d
Cleared Dec 03, 2014
STERILUCENT SELF-SEAL STERILIZATION POUCH
K141412 · FRG
Gs Medical Packaging, Inc.
General Hospital · 188d
Cleared Dec 03, 2014
ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER
K141529 · DQY
Alvimedica Tibbi Urunler Sanayi VE...
Cardiovascular · 177d
Cleared Dec 03, 2014
MAXPOWER RELIEF
K141978 · NUH
Omron Healthcare, Inc.
Neurology · 135d
Cleared Dec 03, 2014
MAC 800 Resting ECG Analysis System
K142288 · DPS
Ge Medical Systems China Co., Ltd.
Cardiovascular · 107d
Cleared Dec 03, 2014
AliveCor Heart Monitor
K142672 · DXH
AliveCor, Inc.
Cardiovascular · 75d
Cleared Dec 03, 2014
ZOLL X Series
K142915 · MKJ
ZOLL Medical Corporation
Cardiovascular · 57d
Cleared Dec 03, 2014
M3290B Philips IntelliVue Information Center iX
K143057 · MSX
Philips Medical Systems
Cardiovascular · 40d
Cleared Dec 03, 2014
ST AIA-PACK PROG II Calibrator Set
K143144 · JIT
Tosoh Bioscience, Inc.
Chemistry · 30d
Cleared Dec 03, 2014
12 mm & Stapler Bladeless Obturators
K143217 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 23d
Cleared Dec 02, 2014
STOPLOSS JONES TUBE
K140290 · OKS
Ljt Surgical, Ltd.
Ophthalmic · 300d
Cleared Dec 02, 2014
CLEARLUMEN THROMBECTOMY SYSTEM
K140296 · QEZ
Walk Vascular, LLC
Cardiovascular · 299d
Cleared Dec 02, 2014
MEDUSA VASCULAR PLUG,
K140796 · KRD
Endoshape, Inc.
Cardiovascular · 246d
Cleared Dec 02, 2014
PGS 5.5 MM CANNULATED PEDICLE SCREW
K141282 · NKB
Pinnacle Spine Group
Orthopedic · 200d
Cleared Dec 02, 2014
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE
K141862 · NBW
H2, Inc.
Chemistry · 145d
Cleared Dec 02, 2014
GMK EXTENSION
K142069 · JWH
Medacta International
Orthopedic · 125d
Cleared Dec 02, 2014
Stryker Infrared Fluorescence (IRF) Imaging System
K142310 · OWN
Stryker Endoscopy
General & Plastic Surgery · 105d
Cleared Dec 02, 2014
Infrared Therapy System
K142340 · ILY
Beijing Huatai Healthcare Technology...
Physical Medicine · 103d
Cleared Dec 02, 2014
Skintact, various other tradenames
K142803 · MKJ
Leonhard Lang GmbH
Cardiovascular · 64d
Cleared Dec 02, 2014
ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
K143164 · BSO
Kimberly Clark Corporation
Anesthesiology · 29d