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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76321–76344 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2002
BODY ARRAY COIL
K013594 · MOS
Usa Instruments, Inc.
Radiology · 84d
Cleared Jan 22, 2002
PREMIER III PHASED ARRAY CTL SPINE COIL
K013595 · MOS
Usa Instruments, Inc.
Radiology · 84d
Cleared Jan 22, 2002
MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION
K013620 · IZF
Medstone Intl., Inc.
Radiology · 78d
Cleared Jan 22, 2002
WEINMANN SOMNOMASK
K013738 · BZD
Gottlieb Weinmann Geraete Fuer...
Anesthesiology · 70d
Cleared Jan 22, 2002
V-GNATHOS SUPRA
K013769 · EJT
Metalor Technologies USA
Dental · 70d
Cleared Jan 22, 2002
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN...
K013793 · LYY
Shen Wei (Usa), Inc.
General Hospital · 69d
Cleared Jan 22, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR...
K013794 · LYY
Shen Wei (Usa), Inc.
General Hospital · 69d
Cleared Jan 22, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR...
K013795 · LYY
Shen Wei (Usa), Inc.
General Hospital · 69d
Cleared Jan 22, 2002
AIMSTEP PREGNANCY
K013857 · DHA
Germaine Laboratories, Inc.
Chemistry · 62d
Cleared Jan 22, 2002
INFINION 0.6T MR IMAGING SYSTEM
K013858 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 62d
Cleared Jan 22, 2002
R&D RET-LINE KIT
K013898 · JPK
R&D Systems, Inc.
Hematology · 60d
Cleared Jan 22, 2002
POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
K014134 · FMC
Supergrade Healthcare Products Sdn. Bhd.
General Hospital · 36d
Cleared Jan 22, 2002
STIMULUS - DISSECTION INSTRUMENTS
K014165 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 34d
Cleared Jan 22, 2002
6F MACH1/34356-XXX
K020028 · DQY
Boston Scientific
Cardiovascular · 18d
Cleared Jan 18, 2002
BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
K010549 · FGE
Medi-Globe Corp.
Gastroenterology & Urology · 326d
Cleared Jan 18, 2002
BIOTECH POWERED WHEELCHAIR, C650PW
K011846 · ITI
Roc Chinese-European Industrial...
Physical Medicine · 220d
Cleared Jan 18, 2002
VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT
K012293 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 182d
Cleared Jan 18, 2002
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER
K012328 · KPO
Di-Chem, Inc.
Gastroenterology & Urology · 179d
Cleared Jan 18, 2002
WATERLASE MILLENNIUM
K012511 · MXF
Biolase Technology, Inc.
Dental · 165d
Cleared Jan 18, 2002
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION
K012547 · KPO
Di-Chem, Inc.
Gastroenterology & Urology · 164d
Cleared Jan 18, 2002
REPROCESSED ELECTROSURGICAL ELECTRODE
K012684 · JOS
Sterilmed, Inc.
General & Plastic Surgery · 157d
Cleared Jan 18, 2002
THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG...
K012943 · NAL
Quantech , Ltd.
Chemistry · 140d
Cleared Jan 18, 2002
DURQ/ QUALIDURA
K013116 · BTA
Ever-Safety Technical Service
General & Plastic Surgery · 122d
Cleared Jan 18, 2002
N LATEX LP(A)
K013128 · DFC
Dade Behring, Inc.
Chemistry · 121d