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

Filters: Cleared only ×
176,076 results
58081–58104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2007
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
K072268 · JPK
R&D Systems, Inc.
Hematology · 97d
Cleared Nov 20, 2007
BIS EEG VISTA MONITOR SYSTEM AND BISX
K072286 · OLW
Aspect Medical Systems, Inc.
Neurology · 96d
Cleared Nov 20, 2007
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
K072521 · FFS
Cook Urological, Inc.
Gastroenterology & Urology · 74d
Cleared Nov 20, 2007
HEMOSTASIS VALVE
K072556 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 71d
Cleared Nov 20, 2007
IMMUNOCAP THYRLOBULIN IMMUNOCAP
K072661 · JNL
Phadia US, Inc.
Immunology · 60d
Cleared Nov 20, 2007
TC-PLUS PRIMARY KNEE SYSTEM
K072858 · JWH
Smith & Nephew, Inc.
Orthopedic · 46d
Cleared Nov 20, 2007
INTEGRADWEB PACS SYSTEM
K072986 · LLZ
Ge Healthcare
Radiology · 28d
Cleared Nov 20, 2007
PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
K073035 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 22d
Cleared Nov 20, 2007
FMRI HARDWARE SYSTEM
K073099 · LNH
Nordicneurolab
Radiology · 18d
Cleared Nov 19, 2007
CAP PLUS
K063050 · MQV
Etex Corp.
Orthopedic · 411d
Cleared Nov 19, 2007
COPA AMD ANTIMICROBIAL WOUND DRESSING
K071371 · FRO
Tyco Healthcare Group LP
General & Plastic Surgery · 187d
Cleared Nov 19, 2007
BIOLOX DELTA CERAMIC FEMORAL HEAD
K071535 · LZO
Zimmer, Inc.
Orthopedic · 167d
Cleared Nov 19, 2007
VALEO PEDICLE SCREW SPINAL SYSTEM
K072022 · NKB
Amedica Corp.
Orthopedic · 119d
Cleared Nov 19, 2007
IMPLANT CENTER
K072030 · DZI
Satelec - Acteon Group
Dental · 118d
Cleared Nov 19, 2007
RIGI-FIX HIP STEM SYSTEM
K072101 · LPH
Implants Intl. , Ltd.
Orthopedic · 111d
Cleared Nov 19, 2007
CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE...
K072202 · DQK
Biosense Webster, Inc.
Cardiovascular · 103d
Cleared Nov 19, 2007
MICROLUX/BLU
K072309 · EAZ
Addent, Inc.
Dental · 94d
Cleared Nov 19, 2007
PFM PICC
K072391 · LJS
Pfm Medical, Inc.
General Hospital · 87d
Cleared Nov 19, 2007
MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM
K072502 · DQK
Ge Medical Systems Information...
Cardiovascular · 74d
Cleared Nov 19, 2007
YUYUAN LATEX EXAMINATION GLOVE, POWDERED
K072639 · LYY
Shandong Yuyuan Latex Gloves Company...
General Hospital · 62d
Cleared Nov 19, 2007
MONDEAL EXTREMITY BONE FIXATION SYSTEM
K072740 · HRS
Mondeal Medical Systems GmbH
Orthopedic · 53d
Cleared Nov 19, 2007
BRIO ACUPUNCTURE NEEDLES
K072778 · MQX
Helio Medical Supplies, Inc.
General Hospital · 52d
Cleared Nov 19, 2007
PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS
K072818 · HRS
Smith & Nephew, Inc.
Orthopedic · 48d
Cleared Nov 19, 2007
SMARTSPONGE PLUS SYSTEM
K073180 · LWH
Clearcount Medical Solutions, Inc.
General & Plastic Surgery · 6d