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
49705–49728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 2010
POWDER - FREE PATIENT EXAMINATION GLOVES
K101565 · LYZ
Zibio Yingjie Medical Products Co., Ltd.
General Hospital · 74d
Cleared Aug 17, 2010
DIGITAL RADIOGRAPHY
K102012 · MQB
Canon Inc. -Medical Equipment Group
Radiology · 32d
Cleared Aug 17, 2010
CURIEPACS (DICOM PACS SOFTWARE)
K102148 · LLZ
Moksha Digital Software Pvt Limited
Radiology · 18d
Cleared Aug 17, 2010
LO-50 LED LIGHT SOURCE
K102167 · NTN
Fiberoptics Technology, Inc.
Gastroenterology & Urology · 15d
Cleared Aug 16, 2010
21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112...
K090947 · LLZ
Totoku Electric Co., Ltd.
Radiology · 500d
Cleared Aug 16, 2010
HUMAN IGA2 KIT FOR USE ON THE SPAPLUS
K100588 · CFN
The Binding Site Group , Ltd.
Immunology · 167d
Cleared Aug 16, 2010
IMC SURGICAL FACE MASK
K100846 · FXX
International Medsurg Connection
General Hospital · 144d
Cleared Aug 16, 2010
ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT,...
K101004 · NHA
Astra Tech, Inc.
Dental · 126d
Cleared Aug 16, 2010
KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC...
K101029 · ELM
Huge Dental Material Co., Ltd.
Dental · 125d
Cleared Aug 16, 2010
LANX FACET SCREW SYSTEM
K101364 · MRW
Lanx, Inc.
Orthopedic · 94d
Cleared Aug 16, 2010
ASCEND BLUE AC MESH
K101462 · FTL
Caldera Medical, Inc.
General & Plastic Surgery · 82d
Cleared Aug 16, 2010
SYNGO TRUED SOFTWARE
K101749 · LLZ
Siemens Medical Solutions
Radiology · 55d
Cleared Aug 13, 2010
ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER
K092875 · NBW
Taidoc Technology Corporation
Chemistry · 329d
Cleared Aug 13, 2010
O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)
K092991 · CBF
Environmental Tectonics Corp.
Anesthesiology · 319d
Cleared Aug 13, 2010
SPECTRA SERIES BREAST PUMP
K093145 · HGX
Uzinmedicare Co.
Obstetrics & Gynecology · 312d
Cleared Aug 13, 2010
2008 HEMODIALYSIS SORBENT SYSTEM
K093362 · FKT
Renal Solutions, Inc.
Gastroenterology & Urology · 289d
Cleared Aug 13, 2010
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS...
K093459 · MST
Phadia US, Inc.
Immunology · 280d
Cleared Aug 13, 2010
POSTURETEK
K093553 · LZW
Perseus Althetics,Llc
Physical Medicine · 269d
Cleared Aug 13, 2010
PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE
K100098 · GEX
Jm System Co., Ltd.
General & Plastic Surgery · 212d
Cleared Aug 13, 2010
PILOT DIODE LASER, MODEL 002-00139
K100143 · GEX
CAO Group, Inc.
General & Plastic Surgery · 206d
Cleared Aug 13, 2010
SPAPLUS
K100179 · CZW
The Binding Site Group , Ltd.
Immunology · 204d
Cleared Aug 13, 2010
MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX
K100786 · NEY
Bsd Medical Corp.
General & Plastic Surgery · 147d
Cleared Aug 13, 2010
PICC WAND PEELABLE SAFETY INTRODUCER
K101150 · DYB
Access Scientific, Inc.
Cardiovascular · 112d
Cleared Aug 13, 2010
FASTPACK TSH IMMUNOASSAY
K101390 · JLW
Qualigen, Inc.
Chemistry · 88d