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
81193–81216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2000
DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB,...
K003598 · DSP
Datascope Corp.
Cardiovascular · 30d
Cleared Dec 21, 2000
INTERACTIVE REAL TIME SCANNING PACKAGE
K003623 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 21, 2000
DW 272 #1
K003634 · EJT
Ivoclar North America, Inc.
Dental · 27d
Cleared Dec 21, 2000
BIO-LOGIC SLEEPSCAN NETLINK
K003681 · OLV
Bio-Logic Systems Corp.
Neurology · 21d
Cleared Dec 21, 2000
CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE,...
K003724 · DTR
Medtronic Vascular
Cardiovascular · 17d
Cleared Dec 21, 2000
SERUM PROTEIN SUBSTITUTE
K003734 · MQL
Sage Biopharma
Obstetrics & Gynecology · 17d
Cleared Dec 21, 2000
CAPNO PROBE A
K984579 · CCK
Optical Sensors, Inc.
Anesthesiology · 729d
Cleared Dec 21, 2000
MSD EMBOLECTOMY BASKET
K991093 · QEW
Metamorphic Surgical Devices, LLC
Cardiovascular · 630d
Cleared Dec 20, 2000
CRIT-LINE MONITOR III (CLM III)
K001763 · MQS
In-Line Diagnostics Corp.
Gastroenterology & Urology · 191d
Cleared Dec 20, 2000
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210
K002308 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 145d
Cleared Dec 20, 2000
RDH BANDAGE
K002550 · KMF
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 125d
Cleared Dec 20, 2000
GOLD CORE POST SOLDER
K002854 · EJT
Jeneric/Pentron, Inc.
Dental · 100d
Cleared Dec 20, 2000
COOLBLU CURING LIGHT
K002925 · EBZ
Dental Systems.Com, Inc.
Dental · 92d
Cleared Dec 20, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K003100 · JCT
Boston Scientific Corp
General & Plastic Surgery · 78d
Cleared Dec 20, 2000
Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
K003118 · DYG
Zcv ,Inc.
Cardiovascular · 76d
Cleared Dec 20, 2000
HAKIM PROGRAMMER AND TRANSMITTER
K003564 · JXG
Codman & Shurtleff, Inc.
Neurology · 30d
Cleared Dec 20, 2000
HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
K003565 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Dec 20, 2000
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0
K003621 · MHX
Agilent Technologies, Inc.
Cardiovascular · 26d
Cleared Dec 20, 2000
REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY...
K003624 · GEI
Arthrocare Corp.
General & Plastic Surgery · 26d
Cleared Dec 20, 2000
DW 273 #1
K003632 · EJS
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 20, 2000
DW 277 #4
K003633 · EJT
Ivoclar North America, Inc.
Dental · 26d
Cleared Dec 20, 2000
PLACEMENT-PLUS
K003642 · LJS
Catheter Innovations, Inc.
General Hospital · 23d
Cleared Dec 20, 2000
CONFORMANCE CHEMISTRY CONTROL C3
K003716 · JJY
Consolidated Technology
Chemistry · 19d
Cleared Dec 20, 2000
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
K003728 · KWS
Tornier
Orthopedic · 16d