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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
55489–55512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 2008
XPERT MRSA/SA BLOOD CULTURE ASSAY
K082140 · NQX
Cepheid
Microbiology · 61d
Cleared Sep 29, 2008
QUICKPIN
K082752 · LHI
Laboratorios Grifols, S.A.
General Hospital · 10d
Cleared Sep 26, 2008
VIDAS AFP ASSAY
K080017 · LOJ
bioMerieux, Inc.
Immunology · 267d
Cleared Sep 26, 2008
DUOFLO CATHETER
K080700 · MJN
Thermopeutix, Inc.
Cardiovascular · 199d
Cleared Sep 26, 2008
HANDHELD ECG MONITOR, MODEL MD100
K080933 · DPS
Beijing Choice Electronic Technololgy...
Cardiovascular · 177d
Cleared Sep 26, 2008
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
K080948 · HET
Olympus Medical Systems Corporation
Obstetrics & Gynecology · 176d
Cleared Sep 26, 2008
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS,...
K081231 · DLZ
Abbott Laboratories
Toxicology · 148d
Cleared Sep 26, 2008
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K081539 · LYZ
Rich Mountain Medical Products, Inc.
General Hospital · 116d
Cleared Sep 26, 2008
FLOWPICC STYLET
K081625 · OBJ
Vasonova, Inc.
Cardiovascular · 108d
Cleared Sep 26, 2008
ACUNAV V ULTRASOUND CATHETER
K081808 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 92d
Cleared Sep 26, 2008
ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY...
K081860 · LZO
Zimmer, Inc.
Orthopedic · 87d
Cleared Sep 26, 2008
UNISYN IMAGE FUSION, VERSION 1.0
K081987 · LLZ
Convergent Imaging Solutions
Radiology · 74d
Cleared Sep 26, 2008
MODIFICATION TO FETCH ASPIRATION CATHETER
K081989 · QEZ
Possis Medical, Inc.
Cardiovascular · 74d
Cleared Sep 26, 2008
SMOOTHKIT+
K082004 · GEX
Osyris
General & Plastic Surgery · 74d
Cleared Sep 26, 2008
SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE
K082029 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 71d
Cleared Sep 26, 2008
SEEPLATE CERVICAL PLATE SYSTEM
K082037 · KWQ
Amedica Corp.
Orthopedic · 71d
Cleared Sep 26, 2008
PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX
K082167 · EHD
Digimed Corporation
Radiology · 57d
Cleared Sep 26, 2008
LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE
K082256 · MWI
Integrated Medical Systems, Inc.
Cardiovascular · 49d
Cleared Sep 26, 2008
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
K082317 · KGI
General Electric Co.
Radiology · 44d
Cleared Sep 26, 2008
LIFEBED PATIENT VIGILANCE SYSTEM
K082366 · DRT
Hoana Medical, Inc.
Cardiovascular · 39d
Cleared Sep 26, 2008
DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE
K082443 · LYZ
Rich Mountain Medical Products, Inc.
General Hospital · 32d
Cleared Sep 26, 2008
UNITED U2 PATELLA
K082469 · JWH
United Orthopedic Corp.
Orthopedic · 30d
Cleared Sep 26, 2008
FINECROSS MG CORONARY MICRO-GUIDE CATHETER
K082519 · KRA
Terumo Medical Corp.
Cardiovascular · 24d
Cleared Sep 26, 2008
OSSTELL ISQ IMPLANT STABILITY METER
K082523 · EKX
Osstell AB
Dental · 24d