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
67441–67464 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2004
CANDELA SMOOTHBEAM LASER SYSTEM
K041242 · GEX
Candela Corp.
General & Plastic Surgery · 195d
Cleared Nov 22, 2004
MEDICULT IVM SYSTEM
K041284 · MQL
Medicult A/S
Obstetrics & Gynecology · 193d
Cleared Nov 22, 2004
MORTON IUI CATHETERS
K041470 · MQF
Fertility Technology Resources, Inc.
Obstetrics & Gynecology · 173d
Cleared Nov 22, 2004
BINDING SITE IGG SUBLCASS OLYMPUS KITS
K042152 · CFN
The Binding Site
Immunology · 105d
Cleared Nov 22, 2004
SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE
K042314 · FMF
Biogen
General Hospital · 88d
Cleared Nov 22, 2004
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER
K042491 · LJS
Becton, Dickinson & CO
General Hospital · 69d
Cleared Nov 22, 2004
S&C-SELF ETCH PR-BOND
K042614 · KLE
S & C Polymer GmbH
Dental · 59d
Cleared Nov 22, 2004
NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K042662 · LLZ
Barco NV Barcoview
Radiology · 55d
Cleared Nov 22, 2004
PET-DOSE
K042746 · KPT
Comecer S.R.L.
Radiology · 49d
Cleared Nov 22, 2004
BBLCHROMAGAR MRSA
K042812 · JSO
Becton, Dickinson & CO
Microbiology · 41d
Cleared Nov 22, 2004
FRC POSTEC PLUS
K042848 · ELR
Ivoclar Vivadent, Inc.
Dental · 38d
Cleared Nov 22, 2004
VENTURE WIRE CONTROL CATHETER, MODEL WCC
K042910 · DQY
Velocimed, Inc.
Cardiovascular · 32d
Cleared Nov 22, 2004
MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2
K042918 · GEX
Endooptiks, Inc.
General & Plastic Surgery · 31d
Cleared Nov 22, 2004
MGP 15 DICOM THEATER
K042942 · LLZ
Barco NV Barcoview
Radiology · 28d
Cleared Nov 22, 2004
MODIFICATION TO PROTEX STABILIZATION SYSTEM
K042953 · NKB
Globus Medical, Inc.
Orthopedic · 27d
Cleared Nov 22, 2004
MX MONOAXIAL PEDICLE SCREW
K042964 · MNH
Scient'X
Orthopedic · 26d
Cleared Nov 22, 2004
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
K043138 · EWL
Atos Medical AB
Ear, Nose, Throat · 10d
Cleared Nov 19, 2004
WEST NILE DETECT IGM ELISA
K041817 · NOP
Inbios Intl., Inc.
Microbiology · 136d
Cleared Nov 19, 2004
SMITH & NEPHEW MODULAR HIP
K042127 · MEH
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Nov 19, 2004
INSTANT-VIEW TROPONIN I TEST
K042227 · MMI
Alfa Scientific Designs, Inc.
Chemistry · 94d
Cleared Nov 19, 2004
MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD
K042347 · NBC
Dade Behring, Inc.
Chemistry · 81d
Cleared Nov 19, 2004
ETEST FOR GEMIFLOXACIN
K042390 · JWY
Ab Biodisk
Microbiology · 78d
Cleared Nov 19, 2004
COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
K042473 · JQC
Cobe Cardiovascular, Inc.
Hematology · 67d
Cleared Nov 19, 2004
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT
K042477 · DDG
Ortho-Clinical Diagnostics, Inc.
Chemistry · 67d