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
49369–49392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2010
ZIP'R3/ ZIP'R3 XTRA SCOOTER
K102358 · INI
Global Fabtech Wheelchair (Shanghai)...
Physical Medicine · 46d
Cleared Oct 04, 2010
ZIP'R4/ ZIP'R4 XTRA SCOOTER
K102361 · INI
Global Fabtech Wheelchair (Shanghai)...
Physical Medicine · 46d
Cleared Oct 04, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K102362 · LYZ
Jiangsu Huayuan Gloves Co., Ltd.
General Hospital · 46d
Cleared Oct 04, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102431 · LYZ
Tangshan Fuqiang Glove Co., Ltd.
General Hospital · 39d
Cleared Oct 04, 2010
NO!NO! SKIN
K102477 · OLP
Radiancy (Israel) , Ltd.
General & Plastic Surgery · 35d
Cleared Oct 04, 2010
MIRADA RT
K102687 · LLZ
Mirada Medical, Ltd.
Radiology · 17d
Cleared Oct 01, 2010
PERFADEX AND PERFADEX WITH THAM
K091989 · KDN
Xvivo Perfusion AB
Gastroenterology & Urology · 456d
Cleared Oct 01, 2010
ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM
K093837 · LIP
Zeus Scientific, Inc. (Zeus)
Microbiology · 290d
Cleared Oct 01, 2010
DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM
K100042 · MAX
Difusion Technologies
Orthopedic · 266d
Cleared Oct 01, 2010
WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS
K101148 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 161d
Cleared Oct 01, 2010
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA,...
K101223 · OBO
Heidelberg Engineering
Ophthalmic · 151d
Cleared Oct 01, 2010
MAGNETOM AERA
K101347 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 141d
Cleared Oct 01, 2010
3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM
K101528 · JOJ
3M Company
General Hospital · 121d
Cleared Oct 01, 2010
MICROMED PD-8K INSULATION DEFECT DETECTOR
K101606 · HFG
Mcgan Technology, LLC
Obstetrics & Gynecology · 115d
Cleared Oct 01, 2010
ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS
K101622 · HSB
Zimmer, Inc.
Orthopedic · 114d
Cleared Oct 01, 2010
ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
K101831 · OSL
Bionostics, Inc.
Hematology · 92d
Cleared Oct 01, 2010
BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT
K101849 · DZE
Bicon, LLC
Dental · 92d
Cleared Oct 01, 2010
TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT
K101880 · DZE
Zimmer Dental, Inc.
Dental · 87d
Cleared Oct 01, 2010
3D SCANNER, MODEL 1230
K101992 · IYE
Sun Nuclear Corp.
Radiology · 78d
Cleared Oct 01, 2010
GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K102104 · IYN
Wipro GE Healthcare Private, Ltd.
Radiology · 66d
Cleared Oct 01, 2010
XIO RTP SYSTEM
K102216 · MUJ
Computerized Medical Systems, Inc.
Radiology · 56d
Cleared Oct 01, 2010
XELIS DENTAL
K102684 · LLZ
Infinitt Co., Ltd.
Radiology · 14d
Cleared Sep 30, 2010
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K093107 · DHB
Siemens Healthcare Diagnostics
Immunology · 364d
Cleared CT Sep 30, 2010
PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
K101200 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 154d