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
53737–53760 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Apr 22, 2009
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
K083374 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 160d
Cleared Apr 22, 2009
FLUID-FILLED TEETHER
K083512 · KKO
Wiltec Industries , Ltd.
Dental · 147d
Cleared Apr 22, 2009
APEX MEDICAL XT AUTO CPAP 9S-005200
K083656 · BZD
Apex Medical Corp.
Anesthesiology · 133d
Cleared Apr 22, 2009
YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U,...
K090058 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 104d
Cleared Apr 22, 2009
MERETE LOCKING BONE PLATE SYSTEM
K090063 · KTT
Merete Medical, Inc.
Orthopedic · 103d
Cleared Apr 22, 2009
INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
K090070 · FST
Invuity, Inc.
General & Plastic Surgery · 100d
Cleared Apr 22, 2009
HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS
K090074 · JOW
Hygia Health Services, Inc.
Cardiovascular · 100d
Cleared Apr 22, 2009
FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
K090116 · FDF
Fujinon, Inc.
Gastroenterology & Urology · 91d
Cleared Apr 22, 2009
BLOOD MONITORING UNIT, MODEL BMU 40
K090147 · DRY
Maquet Cardiopulmonary, AG
Cardiovascular · 91d
Cleared Apr 22, 2009
AVS ANTERIOR LARGE PEEK SPACERS
K090166 · MAX
Stryker Corp.
Orthopedic · 90d
Cleared Apr 22, 2009
SPEC MODEL M-31
K090366 · KXK
Source Production & Equipment Co., Inc.
Radiology · 68d
Cleared Apr 22, 2009
BARCO 5MP MAMMO, MODEL MDMG-5221
K090603 · LLZ
Barco N.V.
Radiology · 48d
Cleared Apr 22, 2009
BLUE SKY BIO PLAN, VERSION .38
K090607 · LLZ
Blue Sky Bio, LLC
Radiology · 47d
Cleared Apr 22, 2009
NOVEL ALIF SPINAL SPACER SYSTEM
K090782 · MAX
Alphatec Spine, Inc.
Orthopedic · 30d
Cleared Apr 22, 2009
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K090799 · NKB
Depuy Spine, Inc.
Orthopedic · 29d
Cleared Apr 22, 2009
PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
K091011 · FWP
Surgical Technology Laboratories, Inc...
General & Plastic Surgery · 13d
Cleared Apr 22, 2009
MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K091087 · GAM
Surgical Devices, Tyco Healthcare...
General & Plastic Surgery · 7d
Cleared Apr 22, 2009
ULTIMUM/ENGAGE/ENGAGE TR
K091137 · DYB
St Jude Medical
Cardiovascular · 2d
Cleared Apr 21, 2009
ONE STEP HCG URINE/SERUM TEST
K072500 · DHA
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 594d
Cleared Apr 21, 2009
NEUTROLUMENPN SYSTEM, MODEL 1000
K082223 · ILY
Neurolumen, LLC
Physical Medicine · 258d
Cleared Apr 21, 2009
APEXUM ABLATOR
K082325 · EKX
Apexum , Ltd.
Dental · 250d
Cleared Apr 21, 2009
ALEUTIAN IBF SYSTEM
K082698 · MAX
K2m, Inc.
Orthopedic · 218d
Cleared Apr 21, 2009
TENS/NMES/FES STIMULATING ELECTRODE
K083350 · GXY
Covidien LP
Neurology · 159d
Cleared Apr 21, 2009
CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
K083554 · JJY
Cliniqa Corporation
Chemistry · 141d