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
60577–60600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2007
EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B...
K061414 · CAW
Pacific Consolidated Industries, LLC
Anesthesiology · 245d
Cleared Jan 22, 2007
SELECT TENS, MODEL 4600S
K061650 · GZJ
Empi
Neurology · 223d
Cleared Jan 22, 2007
EUKARE
K062892 · CGA
Eumed Biotechnology Co., Ltd.
Chemistry · 118d
Cleared Jan 22, 2007
GLASS LOSS OF RESISTANCE SYRINGE
K063018 · CAZ
Busse Hospital Disposables, Inc.
Anesthesiology · 112d
Cleared Jan 22, 2007
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND...
K063351 · NDY
Dade Behring, Inc.
Chemistry · 77d
Cleared Jan 22, 2007
TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT
K063423 · JWH
Howmedica Osteonics
Orthopedic · 70d
Cleared Jan 22, 2007
TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
K063434 · DQA
Radiometer Basel AG
Anesthesiology · 70d
Cleared Jan 22, 2007
MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS
K063439 · LLZ
Mtd, Inc.
Radiology · 70d
Cleared Jan 22, 2007
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199
K063451 · MKZ
Gen-Probe, Inc.
Microbiology · 68d
Cleared Jan 22, 2007
BREAS ISLEEP 20I
K063476 · BZD
Breas Medical AB
Anesthesiology · 67d
Cleared Jan 22, 2007
MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE
K063487 · KTT
Merete Medical GmbH
Orthopedic · 66d
Cleared Jan 22, 2007
COR ANALYZER 1, VERSION 1.4
K063548 · LLZ
Rcadia Medical Imaging , Ltd.
Radiology · 59d
Cleared Jan 22, 2007
TWINKY STAR NF
K063604 · EBF
Voco GmbH
Dental · 49d
Cleared Jan 22, 2007
THERMOGARD THERMAL REGULATION SYSTEM
K063829 · NCX
Alsius Corp.
Neurology · 27d
Cleared Jan 19, 2007
LINGLOCK
K061042 · DYW
Sybron Dental Specialties
Dental · 280d
Cleared Jan 19, 2007
LUNDERQUIST WIRE GUIDE
K061670 · DQX
William Cook Europe Aps
Cardiovascular · 219d
Cleared Jan 19, 2007
A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR
K062027 · DXN
A&D Engineering, Inc.
Cardiovascular · 185d
Cleared Jan 19, 2007
MODIFIED MERCI RETRIEVER, MODEL 90050
K062046 · NRY
Concentric Medical, Inc.
Neurology · 184d
Cleared Jan 19, 2007
CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
K062503 · KWW
Catachem, Inc.
Chemistry · 147d
Cleared Jan 19, 2007
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
K062849 · HRX
Smith & Nephew, Inc.
Orthopedic · 116d
Cleared Jan 19, 2007
THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02
K062868 · DQY
Flowcardia, Inc.
Cardiovascular · 116d
Cleared Jan 19, 2007
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)
K062998 · KWA
Biomet Manufacturing Corp
Orthopedic · 109d
Cleared Jan 19, 2007
INTEGRA MOZAIK BONE REGENERATION MATRIX - STRIPS
K063124 · MQV
Integra Lifesciences Corp.
Orthopedic · 98d
Cleared Jan 19, 2007
MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7
K063208 · JGJ
Diagnostic Chemicals , Ltd.
Chemistry · 88d