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
82297–82320 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 2000
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE...
K001588 · GXI
Arthrocare Corp.
Neurology · 86d
Cleared Aug 17, 2000
SYNTHES SCALLOPED DISTAL TIBIA PLATE
K001793 · LXT
Synthes (Usa)
Orthopedic · 64d
Cleared Aug 17, 2000
OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE
K001858 · KKX
China Nantong Guangda Textile Co., Ltd.
General Hospital · 59d
Cleared Aug 17, 2000
SUREFIT DISPERSIVE ELECTRODE
K002002 · GEI
Conmedcorp
General & Plastic Surgery · 48d
Cleared Aug 17, 2000
NDO SURGICAL SURGICAL OVERTUBE
K002018 · FED
Surgical, Inc.
Gastroenterology & Urology · 45d
Cleared Aug 17, 2000
PRIMAFLOW
K002086 · EBF
Dmg USA, Inc.
Dental · 38d
Cleared Aug 17, 2000
STELKAST PROVEN KNEE SYSTEM
K002281 · JWH
Stelkast Company
Orthopedic · 24d
Cleared Aug 17, 2000
LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM
K002314 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 17d
Cleared Aug 17, 2000
COOLTOUCH II
K002347 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 15d
Cleared Aug 17, 2000
M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER
K002397 · IYN
Agilent Technologies, Inc.
Radiology · 10d
Cleared Aug 17, 2000
MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT
K993042 · MED
Medivators, Inc.
General Hospital · 342d
Cleared Aug 16, 2000
MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000
K001106 · FPA
Creative Plastic Technology
General Hospital · 133d
Cleared Aug 16, 2000
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
K001250 · KDI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 119d
Cleared Aug 16, 2000
NEURO SCAN MEDICAL SYSTEMS A4000
K001562 · IKN
Neuro Scan Labs
Neurology · 89d
Cleared Aug 16, 2000
WMT MODULAR SHOULDER SYSTEM
K001706 · KWS
Wrightmedicaltechnologyinc
Orthopedic · 72d
Cleared Aug 16, 2000
LINKMAX
K001823 · EMA
GC America, Inc.
Dental · 61d
Cleared Aug 16, 2000
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
K001969 · DQY
Medtronic Vascular
Cardiovascular · 49d
Cleared Aug 16, 2000
SURGICAL DYNAMICS SPINAL RETRACTOR
K002008 · HRX
United States Surgical, A Division of...
Orthopedic · 44d
Cleared Aug 16, 2000
WILLI GELLER CREATION & AV PORCELAIN
K002041 · EIH
Jensen Industries, Inc.
Dental · 42d
Cleared Aug 16, 2000
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH...
K002141 · LWJ
Exactech, Inc.
Orthopedic · 30d
Cleared Aug 16, 2000
SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX
K993698 · DRF
Mogul Enterprises
Cardiovascular · 288d
Cleared Aug 15, 2000
CHARTER MEDICAL NEONATAL SYRINGE SET
K000685 · BRZ
Charter Medical, Ltd.
General Hospital · 168d
Cleared Aug 15, 2000
SANSIBAR CPAP SYSTEM
K000888 · BZD
Prym Medical , Ltd.
Anesthesiology · 148d
Cleared Aug 15, 2000
NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE
K002218 · LZA
Shanghai Champion Plastic Products...
General Hospital · 22d