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
38233–38256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 2014
AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE
K132686 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 257d
Cleared May 12, 2014
ENDOCEM ZR
K133042 · KIF
Maruchi
Dental · 227d
Cleared May 12, 2014
ENDOSEAL
K133054 · KIF
Maruchi
Dental · 227d
Cleared May 12, 2014
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
K133378 · PHX
Zimmer, Inc.
Orthopedic · 189d
Cleared May 12, 2014
ZERONA
K133718 · OLI
Erchonia Corporation
General & Plastic Surgery · 159d
Cleared May 12, 2014
S9 ELOUERA
K140124 · BZD
ResMed Corp
Anesthesiology · 116d
Cleared May 12, 2014
SUPERCATH5
K140419 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 83d
Cleared May 12, 2014
1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL
K140606 · MOS
Resonance Innovations, LLC
Radiology · 63d
Cleared May 09, 2014
DUET SYSTEM
K130775 · NTH
Bioview , Ltd.
Pathology · 415d
Cleared May 09, 2014
RITTER IMPLANT SYSTEM
K131557 · DZE
Ritter Implants GmbH CO KG
Dental · 345d
Cleared May 09, 2014
YZ3 PORTABLE SLIT LAMP
K131711 · HJO
Suzhou 66 Vision-Tech Co., Ltd.
Ophthalmic · 332d
Cleared May 09, 2014
A9800 ANESTHESIA WORKSTATION
K131790 · BSZ
Oricare, Inc.
Anesthesiology · 325d
Cleared May 09, 2014
SINGLE-SITE PORT
K133203 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 204d
Cleared May 09, 2014
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K133251 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 199d
Cleared May 09, 2014
LEKSELL GAMMA KNIFE PERFEXION
K133565 · IWB
Elekta Instrument AB
Radiology · 170d
Cleared May 09, 2014
ADX4000W
K134055 · MUH
Dexcowin Co., Ltd.
Radiology · 129d
Cleared May 09, 2014
CANDELA GENTLEMAX FAMILY OF LASER SYSTEM
K140122 · GEX
Candela Corp.
General & Plastic Surgery · 113d
Cleared May 09, 2014
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
K140354 · LSL
Abbott Molecular, Inc.
Microbiology · 86d
Cleared May 08, 2014
MRNA APPLIANCE
K130067 · LRK
Biomodeling Solutions, Lls
Dental · 483d
Cleared May 08, 2014
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
K132711 · LBS
Carolina Liquid Chemistries Corp.
Chemistry · 252d
Cleared May 08, 2014
STALIF C(R)
K133200 · OVE
Centinel Spine, Inc.
Orthopedic · 203d
Cleared May 08, 2014
ASTHMA MONITOR AM3
K133722 · BZG
Eresearch Technology
Anesthesiology · 154d
Cleared May 08, 2014
NOBELACTIVE WIDE PLATFORM (WP)
K133731 · DZE
Nobel Biocare AB
Dental · 153d
Cleared May 08, 2014
SCINTILLATION GAMMA CAMERA
K140206 · KPS
Ddd-Diagnostic A/S
Radiology · 101d