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
49513–49536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2010
EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST...
K100017 · OSK
Euroimmun Us, Inc.
Immunology · 252d
Cleared Sep 13, 2010
OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
K100899 · FEQ
Keymed (Medical & Industrial...
Gastroenterology & Urology · 166d
Cleared Sep 13, 2010
RXPEAKFLOW
K101380 · BZH
Noble Marketing
Anesthesiology · 119d
Cleared Sep 13, 2010
CLEARARCH
K101676 · DYW
Ormco Corp.
Dental · 90d
Cleared Sep 13, 2010
COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
K101783 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 80d
Cleared Sep 13, 2010
AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
K101824 · EZL
Amsino International, Inc.
Gastroenterology & Urology · 74d
Cleared Sep 13, 2010
MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL...
K102173 · MSH
Moldex/Metric, Inc.
General Hospital · 42d
Cleared Sep 10, 2010
ACTA VESSEL OCCLUSION SYSTEM (VOS)
K091952 · KRD
Nfocus Neuromedical, Inc.
Cardiovascular · 436d
Cleared Sep 10, 2010
STERILE SALINE SOLUTION
K093367 · LPN
Cachet Pharmaceuticals Pvt. , Ltd.
Ophthalmic · 316d
Cleared Sep 10, 2010
SURGICAL FACE MASK
K093901 · FXX
Epard Protective Products, Ltd.
General Hospital · 262d
Cleared Sep 10, 2010
STLASE DIODE LASER
K094049 · GEX
Dental Photonics, Inc.
General & Plastic Surgery · 253d
Cleared Sep 10, 2010
KIRSCHNER AND GUIDE WIRES
K100736 · HTY
Smt Schilling Metalltechnik GmbH
Orthopedic · 179d
Cleared Sep 10, 2010
TINA-QUANT ALBUMIN GEN 2
K101203 · DCF
Roche Diagnostics
Chemistry · 134d
Cleared Sep 10, 2010
STAXX XD SYSTEM
K101288 · MQP
Spine Wave, Inc.
Orthopedic · 126d
Cleared Sep 10, 2010
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
K101425 · LRG
Siemens Healthcare Diagnostics
Microbiology · 113d
Cleared Sep 10, 2010
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
K101696 · HWC
Zimmer, Inc.
Orthopedic · 86d
Cleared Sep 10, 2010
ENDEAVOUR MONITORING SYSTEM
K102004 · MHX
Mindray DS USA, Inc.
Cardiovascular · 57d
Cleared Sep 10, 2010
NUGARD NITILE GREY COLOR
K102230 · LZA
Terang Nusa Sdn Bhd
General Hospital · 32d
Cleared Sep 10, 2010
ELECSYS FERRITIN CALCHECK 5
K102267 · JJX
Roche Diagnostics
Chemistry · 32d
Cleared Sep 10, 2010
BLOOD PRESSURE METER, MODEL CH-658
K102303 · DXN
Citizen Systems Japan Co., Ltd.
Cardiovascular · 25d
Cleared Sep 10, 2010
TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET
K102430 · DSA
Tyco Electronics Corporation
Cardiovascular · 15d
Cleared Sep 10, 2010
E.S.O. (ELECTRO SENSOR OXI)
K102442 · DQA
Ld Technology, LLC
Anesthesiology · 15d
Cleared Sep 09, 2010
COBAS 8000 MODULAR SERIES ANALYZER
K100853 · DCF
Roche Diagnostics Corp.
Chemistry · 167d
Cleared Sep 09, 2010
BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
K100985 · NHA
BioHorizons Implant Systems, Inc.
Dental · 153d