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
37033–37056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2014
POLARIS SPINAL SYSTEM - HA COATED
K141804 · NKB
Biomet Spine, LLC
Orthopedic · 84d
Cleared Sep 25, 2014
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
K141897 · KWP
Synthes USA Products, LLC
Orthopedic · 73d
Cleared Sep 25, 2014
ESOFLIP ES
K142000 · PIE
Crospon, Ltd.
Gastroenterology & Urology · 64d
Cleared Sep 25, 2014
Optima XR200amx, Optima XR220amx
K142383 · IZL
Ge Medical Systems, LLC
Radiology · 30d
Cleared Sep 25, 2014
FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup),...
K142408 · LDJ
Polymed Therapeutics, Inc.
Toxicology · 28d
Cleared Sep 25, 2014
TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
K142546 · DRE
Spectranetics, Inc.
Cardiovascular · 15d
Cleared Sep 24, 2014
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
K132121 · PZI
Nova Biomedical Corporation
Chemistry · 441d
Cleared Sep 24, 2014
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
K133456 · NIE
C.R. Bard, Inc.
Gastroenterology & Urology · 316d
Cleared Sep 24, 2014
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM
K140097 · CBH
Applied Medical Technology, Inc.
Anesthesiology · 253d
Cleared Sep 24, 2014
CONCHASMART BREATHING CIRCUIT
K140556 · BTT
Teleflex, Inc.
Anesthesiology · 203d
Cleared Sep 24, 2014
LUCID LY
K140837 · GEX
Bio-Med USA, Inc.
General & Plastic Surgery · 175d
Cleared Sep 24, 2014
SMARTGRAFT 30 SYSTEM
K141591 · MUU
Ingeneron, Inc.
General & Plastic Surgery · 103d
Cleared Sep 24, 2014
GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM
K141829 · NBW
Ceragem Medisys, Inc.
Chemistry · 79d
Cleared Sep 24, 2014
REACH ACCESS TELEMEDICINE DOSE CALCULATOR
K142123 · NDC
Reach Health, Inc.
General Hospital · 51d
Cleared Sep 24, 2014
Ultraverse 035 PTA Balloon Dilatation Catheter
K142261 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 41d
Cleared Sep 24, 2014
Palomar Icon Aesthetic System
K142376 · GEX
Cynosure, Inc.
General & Plastic Surgery · 29d
Cleared Sep 23, 2014
INTRAMEDULLARY NAIL AND SCREWS-NEONAIL
K141103 · HSB
Neoortho Produtos Ortopedicos S/A
Orthopedic · 147d
Cleared Sep 23, 2014
BIOSPACE BODY COMPOSITION ANALYZER
K141483 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 110d
Cleared Sep 23, 2014
OPTIO-C ANTERIOR CERVICAL SYSTEM
K141500 · KWQ
Zimmer Spine, Inc.
Orthopedic · 109d
Cleared Sep 23, 2014
STERILIZATION CASSETTE
K141616 · KCT
Oticon Medical AB
General Hospital · 99d
Cleared Sep 23, 2014
4WEB SPINAL IMPLANT PRODUCTS
K142112 · MAX
4Web, Inc.
Orthopedic · 50d
Cleared Sep 22, 2014
ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED
K140077 · HEB
Albaad , Ltd.
Obstetrics & Gynecology · 252d
Cleared Sep 22, 2014
STARBRIGHT 5% SODIUM FLUORIDE VARNISH
K140349 · LBH
Nanova Biomaterials, Inc.
Dental · 215d
Cleared CT Sep 22, 2014
PICOSURE WORKSTATION
K140719 · GEX
Cynosure, Inc.
General & Plastic Surgery · 185d