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
53881–53904 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2009
REGENEREX PATELLA COMPONENTS
K083782 · MBH
Biomet Manufacturing Corp
Orthopedic · 105d
Cleared CT Apr 03, 2009
GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER
K090140 · DTK
William Cook Europe Aps
Cardiovascular · 72d
Cleared Apr 03, 2009
MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM
K090249 · DPS
Harbinger Medical, Inc.
Cardiovascular · 60d
Cleared Apr 03, 2009
PREMISE MODIFIED
K090292 · EBF
Kerr Corp.
Dental · 57d
Cleared Apr 03, 2009
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN...
K090327 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 53d
Cleared Apr 03, 2009
TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
K090352 · BTR
Covidien
Anesthesiology · 51d
Cleared Apr 03, 2009
PROVENT PROFESSIONAL SLEEP APNEA THERAPY
K090398 · OHP
Ventus Medical, Inc.
Dental · 45d
Cleared Apr 03, 2009
RIGIDFIX BIOCRYL CROSS PIN KITS
K090669 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 21d
Cleared Apr 03, 2009
YIELD MINI DOPPLER SYSTEM
K090743 · IYN
Broncus Technologies, Inc.
Radiology · 14d
Cleared Apr 03, 2009
V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL...
K090805 · INI
Pride Mobility Products Corp.
Physical Medicine · 9d
Cleared Apr 03, 2009
PINNACLE3 SMARTARC
K090808 · MUJ
Philips Medical Systems, Inc.
Radiology · 9d
Cleared Apr 03, 2009
MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)
K090878 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 3d
Cleared Apr 02, 2009
STIWELL MED4
K080950 · IPF
Otto Bock, Austria GmbH
Physical Medicine · 364d
Cleared Apr 02, 2009
BLACK WIDOW ANTERIOR BUTTRESS PLATE
K081770 · KWQ
Omni Surgical, L.P.
Orthopedic · 283d
Cleared Apr 02, 2009
ASAP WOUND DRESSING GEL
K082333 · FRO
American Biotech Labs
General & Plastic Surgery · 231d
Cleared Apr 02, 2009
REPLICATION MEDICAL VESSEL GUARD
K082782 · OMR
Replication Medical, Inc.
Cardiovascular · 192d
Cleared Apr 02, 2009
INTERGRO DBM
K082793 · MQV
Biomet Spine
Orthopedic · 191d
Cleared Apr 02, 2009
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL),...
K083386 · CJY
Siemens Healthcare Diagnostics
Chemistry · 136d
Cleared Apr 02, 2009
COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET
K083482 · FPA
Cook Vascular, Inc.
General Hospital · 129d
Cleared Apr 02, 2009
LNCS OXIMETRY SENSORS
K083622 · DQA
Masimo Corporation
Anesthesiology · 115d
Cleared Apr 02, 2009
PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
K083693 · CBK
Covidien, Formerly Nellcor Puritan...
Anesthesiology · 111d
Cleared Apr 02, 2009
ZETAJET
K090003 · KZE
Bioject, Inc.
General Hospital · 90d
Cleared Apr 02, 2009
ATMOS S041 WOUND
K090130 · OMP
Atmos, Inc.
General & Plastic Surgery · 71d
Cleared Apr 02, 2009
NEOSALUS CREAM
K090585 · FRO
Quinnova Pharmaceuticals
General & Plastic Surgery · 29d