FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
141601–141624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1986
SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1
K864506 · DSI
Spacelabs, Inc.
Cardiovascular · 11d
Cleared Nov 25, 1986
LP ARTHROSCOPIC THIGH HOLDING DEVICE
K864513 · HRX
Twin Falls Orthopedic Associates, P.A.
Orthopedic · 12d
Cleared Nov 24, 1986
HAYES VAGINAL SHIELD
K862478 · HDF
Franklin Medical USA, Inc.
Obstetrics & Gynecology · 147d
Cleared Nov 24, 1986
MIDDLE EAR VIEWER AND FLUID COLLECTOR
K862903 · JZF
Steven K. Juhn
Ear, Nose, Throat · 116d
Cleared Nov 24, 1986
AMR RESEARCH TONOMETER
K862958 · LCH
Associated Medical Representatives
Chemistry · 111d
Cleared Nov 24, 1986
BILIRUBIN TOTAL
K863056 · CIG
J. D. Assoc.
Chemistry · 104d
Cleared Nov 24, 1986
GLUCOMETER-E
K863102 · CGA
J. D. Assoc.
Chemistry · 103d
Cleared Nov 24, 1986
FERROFAST
K863109 · JIY
J. D. Assoc.
Chemistry · 103d
Cleared Nov 24, 1986
7.5 MHZ LINEAR SMALL PARTS PROBE
K863338 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Nov 24, 1986
MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA
K863361 · HHR
Cooper Lasersonics, Inc.
Obstetrics & Gynecology · 83d
Cleared Nov 24, 1986
URESIL CAROTID SHUNT
K863558 · DWF
Uresil Corp.
Cardiovascular · 73d
Cleared Nov 24, 1986
CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER
K863583 · LNK
Laser Media
Gastroenterology & Urology · 76d
Cleared Nov 24, 1986
FLEXMEDICS NITINOL ARCH WIRE
K863742 · DZC
Flexmedics
Dental · 62d
Cleared Nov 24, 1986
MULTI-ANALYTE LIN-TROL
K863751 · JJY
Sigma Diagnostics, Inc.
Chemistry · 60d
Cleared Nov 24, 1986
CO-OXIMETER SOLUTIONS
K863825 · JKS
D.R.G. Scientific Industries
Chemistry · 55d
Cleared Nov 24, 1986
LIQUI-SERA COMBO LIGAND/TDM CONTROLS
K863849 · JJY
Biodiagnostic Intl
Chemistry · 55d
Cleared Nov 24, 1986
BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.
K863880 · CHL
D.R.G. Scientific Industries
Chemistry · 49d
Cleared Nov 24, 1986
UREA NITROGEN TEST
K863889 · CDL
U. S. Diagnostics, Inc.
Chemistry · 49d
Cleared Nov 24, 1986
IQ UREA NITROGEN
K863901 · JGZ
Bd Becton Dickinson Vacutainer...
Chemistry · 48d
Cleared Nov 24, 1986
SHAPE-ACTIO METAL TOXICOLOGY CONTROL
K863915 · DIE
Shape Products Co.
Toxicology · 47d
Cleared Nov 24, 1986
DAIG TYPE O4 VS-1 CONNECTOR
K863921 · DTB
Daig Corp.
Cardiovascular · 47d
Cleared Nov 24, 1986
TRIGLYCERIDES
K863923 · CDT
Tech-Co, Inc.
Chemistry · 47d
Cleared Nov 24, 1986
URIC ACID
K863924 · KNK
Tech-Co, Inc.
Chemistry · 47d
Cleared Nov 24, 1986
UREA NITROGEN(BUN)
K863925 · CDQ
Tech-Co, Inc.
Chemistry · 47d