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
69433–69456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 2004
LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE,...
K033699 · DZE
Zest Anchors, Inc.
Dental · 149d
Cleared Apr 22, 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
K033727 · CEW
Nichols Institute Diagnostics
Chemistry · 146d
Cleared Apr 22, 2004
OXYGEN DIVERTER VALVE
K033914 · BZD
Resmed, Ltd.
Anesthesiology · 126d
Cleared Apr 22, 2004
RESOLUTION HEMOSTASIS CLIPPING DEVICE
K040148 · MCH
Boston Scientific Corp
General & Plastic Surgery · 90d
Cleared Apr 22, 2004
MASIMO SET INTELLIVUE PULSE OXIMETER MODULE
K040259 · DQA
Masimo Corp.
Anesthesiology · 78d
Cleared Apr 22, 2004
ULTRASONIC SCALER ELEGANCE MS-10 (25K)
K040396 · ELC
Rolence Enteprise, Inc.
Dental · 65d
Cleared Apr 22, 2004
NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400,...
K040495 · EGJ
Naimco, Inc.
Physical Medicine · 56d
Cleared Apr 22, 2004
AMS APOGEE VAULT SUSPENSION SYSTEM
K040537 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 51d
Cleared Apr 22, 2004
OTTER SAFETY SYRINGE
K040545 · MEG
Otter (China) Technology Co., Ltd.
General Hospital · 51d
Cleared Apr 22, 2004
GC INITIAL MC, AL AND LF
K040567 · EIH
GC America, Inc.
Dental · 49d
Cleared Apr 22, 2004
NMX-1000
K040584 · GEI
Neomedix Corp.
General & Plastic Surgery · 48d
Cleared Apr 22, 2004
MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT...
K040607 · LZA
Pt. Medisafe Technologies
General Hospital · 45d
Cleared Apr 22, 2004
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K040743 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 30d
Cleared Apr 22, 2004
VANGUARD PATELLA COMPONENTS
K040770 · JWH
Biomet Manufacturing, Inc.
Orthopedic · 28d
Cleared Apr 22, 2004
ACCU-CHEK GO SYSTEM
K040796 · LFR
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Apr 21, 2004
THE GNATHOMETER
K033092 · JEY
Ortho Gnathics, LLC
Dental · 205d
Cleared Apr 21, 2004
MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK
K033630 · DZE
Rhein 83 Srl
Dental · 156d
Cleared Apr 21, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K034056 · MNH
Medtronic Sofamor Danek
Orthopedic · 113d
Cleared Apr 21, 2004
UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT
K040117 · EIA
Arrow Industries, LLC
Dental · 92d
Cleared Apr 21, 2004
HITACHI PRESTO
K040902 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 14d
Cleared Apr 21, 2004
INFANT INCUBATOR, MODEL CHS-I1000
K040910 · FMZ
Choong Wae Medical Corp.
General Hospital · 13d
Cleared Apr 20, 2004
MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE
K033006 · LLZ
Barco NV Barcoview
Radiology · 270d
Cleared Apr 20, 2004
STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE
K033123 · HLI
Carl Zeiss Meditec, Inc.
Radiology · 203d
Cleared Apr 20, 2004
ENDOSCOUT
K033485 · LNH
Robin Medical, Inc.
Radiology · 168d