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
50329–50352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 2010
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02...
K092705 · OOI
Abbott Molecular, Inc.
Microbiology · 267d
Cleared May 28, 2010
VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED
K093264 · LYZ
Qingdao Lang Hui Import & Export Co.,...
General Hospital · 221d
Cleared May 28, 2010
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44...
K100151 · KWY
Omnlife Science
Orthopedic · 129d
Cleared May 28, 2010
REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
K100254 · NLH
Ascent Healthcare Solutions
Cardiovascular · 120d
Cleared May 28, 2010
FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY
K100427 · DRG
Taidoc Technology Corporation
Cardiovascular · 101d
Cleared May 28, 2010
AMEDA PLATINUM BREAST PUMP
K100435 · HGX
Evenflo Company, Inc.
Obstetrics & Gynecology · 101d
Cleared May 28, 2010
RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880,...
K100554 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 91d
Cleared May 28, 2010
VATEA ENDONTIC IRRIGATION SYSTEM
K100606 · NYL
Redent-Nova , Ltd.
Dental · 86d
Cleared May 28, 2010
MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D
K100617 · DQA
Masimo Corporation
Anesthesiology · 85d
Cleared May 28, 2010
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE...
K101275 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 22d
Cleared May 27, 2010
HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION...
K090191 · NJR
Handylab, Inc.
Microbiology · 485d
Cleared May 27, 2010
GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025
K091168 · NBW
Infopia Co, Ltd.
Chemistry · 400d
Cleared May 27, 2010
MAIA, MODEL 1
K092187 · HPT
Centervue S.P.A.
Ophthalmic · 310d
Cleared May 27, 2010
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER
K093275 · PHX
Exactech, Inc.
Orthopedic · 220d
Cleared May 27, 2010
MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
K093902 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 156d
Cleared May 27, 2010
NOVATION CROWN CUP GXL LINERS
K100269 · LPH
Exactech, Inc.
Orthopedic · 118d
Cleared May 27, 2010
FUSION MEDICAL RING LOCK SYSTEM
K100857 · KTT
John J Riccio
Orthopedic · 62d
Cleared May 26, 2010
AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES
K090379 · BTA
Avita Corporation
General & Plastic Surgery · 463d
Cleared May 26, 2010
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
K093973 · HCG
Codman & Shurtleff, Inc.
Neurology · 153d
Cleared May 26, 2010
SYNGO.CT CORONARY ANALYSIS
K100637 · JAK
Siemens AG Medical Solutions
Radiology · 82d
Cleared May 26, 2010
COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)
K100656 · IRP
Wonjin Mulsan Co., Ltd.
Physical Medicine · 79d
Cleared May 26, 2010
SELF CATH CATHETER
K100878 · EZD
Coloplast Manufacturing Us, LLC
Gastroenterology & Urology · 57d
Cleared May 26, 2010
IQVITALS AND IQVITALS SYSTEM
K100913 · DXN
Brentwood Medical Technology Corp.
Cardiovascular · 55d
Cleared May 26, 2010
U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118
K100942 · FLL
Taidoc Technology Corporation
General Hospital · 51d