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
77905–77928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 2001
MACROPORE SURGIWRAP (TS)
K012025 · FTL
Macropore Biosurgery, Inc.
General & Plastic Surgery · 158d
Cleared Dec 03, 2001
ENT LASERVISION
K012071 · GEX
Union Medical USA
General & Plastic Surgery · 154d
Cleared Dec 03, 2001
COMPANION MODEL 221, 321, 421
K012258 · INI
Golden Technologies, Inc.
Physical Medicine · 138d
Cleared Dec 03, 2001
TRIMAX
K012268 · FYA
Standard Textile Co., Inc.
General Hospital · 137d
Cleared Dec 03, 2001
MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY...
K012380 · HAW
Stryker Leibinger
Neurology · 130d
Cleared Dec 03, 2001
RESORBABLE NO PROFILE SCREW AND WASHER
K012469 · HWC
Biomet Manufacturing, Inc.
Orthopedic · 123d
Cleared Dec 03, 2001
SOFT TISSUE SCREW AND WASHER
K012572 · HWC
Biomet, Inc.
Orthopedic · 116d
Cleared Dec 03, 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · HWC
Synthes (Usa)
Orthopedic · 90d
Cleared Dec 03, 2001
APPLIED ACCESS SEAL
K012968 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 90d
Cleared Dec 03, 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · HWC
Synthes (Usa)
Orthopedic · 84d
Cleared Dec 03, 2001
AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB...
K013231 · BSP
Avid N.I.T., Inc.
Anesthesiology · 67d
Cleared Dec 03, 2001
NIPRO SAFELET CATH
K013287 · FOZ
Nipro Medical Corp.
General Hospital · 62d
Cleared Dec 03, 2001
NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND...
K013288 · LYY
Sgmp Co., Ltd.
General Hospital · 62d
Cleared Dec 03, 2001
REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600
K013328 · IMC
Remington Products Company, LLC
Physical Medicine · 59d
Cleared Dec 03, 2001
MICROMARK II TISSUE MARKER,MODEL C1535
K013413 · NEU
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 49d
Cleared Dec 03, 2001
SIMPLICITY CLASSIC WING QD INFUSION SET
K013502 · FPA
Sterling Medivations, Inc.
General Hospital · 42d
Cleared Dec 03, 2001
MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT...
K013624 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 28d
Cleared Dec 03, 2001
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES
K013657 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 27d
Cleared Dec 03, 2001
XPLAN 2.2 WITH THE BODY SYSTEM
K013661 · MUJ
Radionics, A Division of Tyco...
Radiology · 27d
Cleared Dec 03, 2001
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K013772 · LXT
Howmedica Osteonics
Orthopedic · 20d
Cleared Dec 03, 2001
TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS
K013849 · ITX
Tetrad Corp.
Radiology · 13d
Cleared Dec 03, 2001
PAIN CARE 3200
K013928 · MEB
Breg, Inc.
General Hospital · 5d
Cleared Nov 30, 2001
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
K011043 · JXA
Osmetech
Microbiology · 239d
Cleared Nov 30, 2001
ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA...
K011479 · CGA
Inverness Medical Innovations, Inc.
Chemistry · 200d