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

Filters: Cleared only ×
176,076 results
57217–57240 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2008
AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX
K073470 · MAX
Stryker Spine
Orthopedic · 87d
Cleared Mar 06, 2008
MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
K080155 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 43d
Cleared Mar 06, 2008
SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012
K080171 · KNW
Sanarus Medical, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 05, 2008
ALICIA MENSTRUAL CUP
K070965 · HHE
Alicia International Pty , Ltd.
Obstetrics & Gynecology · 335d
Cleared Mar 05, 2008
MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
K071244 · DXQ
Medline Industries, Inc.
Cardiovascular · 307d
Cleared Mar 05, 2008
ABX PENTRA URINE CAL
K071779 · JIX
Horiba Abx
Chemistry · 247d
Cleared Mar 05, 2008
QUANTA LITE CCP3.1 IGG/IGA ELISA
K072944 · NHX
Inova Diagnostics, Inc.
Immunology · 140d
Cleared Mar 05, 2008
PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM
K073118 · NBW
Diagnostic Devices, Inc.
Chemistry · 121d
Cleared Mar 05, 2008
IVS TUNNELLER DEVICES
K073164 · FTL
Covidien UK Manufacturing, Ltd.
General & Plastic Surgery · 117d
Cleared Mar 05, 2008
IONTOPHORESIS SYSTEM
K073276 · EGJ
Acclarent, Inc.
Physical Medicine · 105d
Cleared Mar 05, 2008
VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM
K073279 · GCJ
Visionsense, Ltd.
General & Plastic Surgery · 105d
Cleared Mar 05, 2008
BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE
K073299 · LYY
Betel Care Sdn. Bhd.
General Hospital · 103d
Cleared Mar 05, 2008
CAPIOX CIRCUIT CONNECTORS
K073474 · DTL
Terumo Corp.
Cardiovascular · 85d
Cleared Mar 05, 2008
ANCHORAGE ACCESS KIT
K073507 · ODC
Epitek, Inc.
Gastroenterology & Urology · 83d
Cleared Mar 05, 2008
PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA...
K073544 · KRD
Rj Medical, Inc.
Cardiovascular · 78d
Cleared Mar 05, 2008
LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
K073552 · FEN
Laborie Medical Technologies, Corp.
Gastroenterology & Urology · 78d
Cleared Mar 05, 2008
CAMLOG IMPLANT SYSTEM ABUTMENTS
K073553 · NHA
Altatec GmbH
Dental · 78d
Cleared Mar 05, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML)...
K073589 · LON
Becton, Dickinson & CO
Microbiology · 76d
Cleared Mar 05, 2008
XTRAC ULTRA 2, MODEL AL10000
K073659 · GEX
Photo Medex, Inc.
General & Plastic Surgery · 70d
Cleared Mar 05, 2008
VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR)
K080066 · LZA
Gx Corporation Sdn Bhd
General Hospital · 55d
Cleared Mar 05, 2008
SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR
K080193 · HQD
Synergeyes, Inc.
Ophthalmic · 40d
Cleared Mar 05, 2008
HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200
K080322 · DHB
Hycor Biomedical, Inc.
Immunology · 28d
Cleared Mar 05, 2008
COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND...
K080340 · KNT
Novartis Nutrition Corp.
Gastroenterology & Urology · 26d
Cleared Mar 05, 2008
RADIO BIOAQUACARE
K080471 · FRO
Bioartificial Gel Technologies...
General & Plastic Surgery · 13d