FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81697–81720 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 15, 2000
NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
K002220 · LZA
Shanghai Champion Plastic Products...
General Hospital · 22d
Cleared Aug 15, 2000
SURGICAL DRAPES
K002419 · KKX
Allegiance Healthcare Coporation
General Hospital · 7d
Cleared Aug 15, 2000
V QUICK PATCH
K993934 · DRX
Vq Corp.
Cardiovascular · 271d
Cleared Aug 14, 2000
BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE
K000421 · KGO
Ssl Americas, Inc. (Regent Medical)
General Hospital · 188d
Cleared Aug 14, 2000
NEOLUS NEEDLE
K001572 · FMI
Terumo Europe N.V.
General Hospital · 84d
Cleared Aug 14, 2000
DANA DIABECARE
K001604 · LZG
Sooil Development Co., Ltd.
General Hospital · 82d
Cleared Aug 14, 2000
BABY DOPPLEX 4000 (BD4000)
K001677 · HGM
Huntleigh Diagnostics , Ltd.
Obstetrics & Gynecology · 74d
Cleared Aug 14, 2000
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
K001810 · JIR
Flexsite Diagnostics, Inc.
Chemistry · 60d