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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
39337–39360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 2014
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
K132733 · HTN
Orthohelix Surgical Designs, Inc.
Orthopedic · 122d
Cleared Jan 03, 2014
FUSION SINGLE LINK
K132923 · KLE
Angelus Industria DE Productos...
Dental · 107d
Cleared Jan 03, 2014
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
K133146 · MSS
Bausch & Lomb
Ophthalmic · 78d
Cleared Jan 03, 2014
Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2...
K133224 · MBI
Conmed Corporation
Orthopedic · 74d
Cleared Jan 03, 2014
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K133312 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 67d
Cleared Jan 03, 2014
PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM,...
K133645 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 37d
Cleared Jan 03, 2014
TRU FLU
K133714 · PSZ
Meridian Bioscience, Inc.
Microbiology · 29d
Cleared Jan 02, 2014
HYDROFERA BLUE PU BACTERIOSTATIC DRESSING
K130670 · FRO
Hydrofera, LLC
General & Plastic Surgery · 296d
Cleared Jan 02, 2014
SOMATOM DEFINITION AS OPEN
K130901 · JAK
Siemens Medical Systems, Inc.
Radiology · 276d
Cleared Jan 02, 2014
FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
K131364 · FBO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 234d
Cleared Jan 02, 2014
LIGHTSCALPEL
K132661 · GEX
Lightscalpel, LLC
General & Plastic Surgery · 129d
Cleared Jan 02, 2014
SPEC MODEL M15
K132969 · KXK
Source Production & Equipment Co., Inc.
Radiology · 101d
Cleared Jan 02, 2014
GELPOINT PATH TRANSANAL ACCESS PLATFORM
K133393 · FER
Applied Medical Resources Corp.
Gastroenterology & Urology · 58d
Cleared Jan 02, 2014
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM...
K133512 · CDD
Siemens Healthcare Diagnostics
Chemistry · 48d
Cleared Dec 31, 2013
ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
K131053 · ERL
The Anspach Effort, Inc.
Ear, Nose, Throat · 259d
Cleared Dec 31, 2013
NASAL EASE ALLERGY BLOCKER
K132520 · NUP
Hi-Tech Pharmacal, Inc.
Ear, Nose, Throat · 141d
Cleared Dec 31, 2013
REPROCESSED DILATING TIP TROCARS
K132629 · NLM
Stryker Sustainability Solutions
Gastroenterology & Urology · 131d
Cleared Dec 31, 2013
UNBALLOON NON-OCCLUSION MODELING CATHETER
K133026 · DQY
LeMaitre Vascular, Inc.
Cardiovascular · 96d
Cleared Dec 31, 2013
TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS,...
K133081 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 92d
Cleared Dec 31, 2013
M1 CAPNOGRAPHY MASK
K133806 · CCK
Monitor Mask, Inc.
Anesthesiology · 15d
Cleared Dec 30, 2013
CLIQ DV-300 ASPIRATOR
K132308 · JCX
Ding Hwa Co., Ltd.
General & Plastic Surgery · 158d
Cleared Dec 30, 2013
MONUMENT SPACERS
K132559 · OVD
Globus Medical, Inc.
Orthopedic · 137d
Cleared Dec 30, 2013
VISUM BLADE LED SURGICAL LIGHTING SYSTEM
K132747 · FSY
Stryker Communications
General & Plastic Surgery · 118d
Cleared Dec 30, 2013
SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR...
K132867 · MBI
Cayenne Medical, Inc.
Orthopedic · 108d