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
76825–76848 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2002
PRECISION PLUS TUNA OFFICE SYSTEM
K014224 · GEI
Vidamed, Inc.
General & Plastic Surgery · 28d
Cleared Jan 23, 2002
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING...
K020019 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 20d
Cleared Jan 22, 2002
DIOMED 15 DIODE LASER
K012398 · GEX
Diomed, Ltd.
General & Plastic Surgery · 179d
Cleared Jan 22, 2002
VANGUARD REPROCESSED INFLATION DEVICES
K012480 · MAV
Vanguard Medical Concepts, Inc.
Cardiovascular · 173d
Cleared Jan 22, 2002
CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP...
K012602 · FXX
Crosstex Intl.
General Hospital · 162d
Cleared Jan 22, 2002
UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES
K013163 · LYY
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 123d
Cleared Jan 22, 2002
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K013262 · LYY
Great Glove (Thailand) Co. , Ltd.
General Hospital · 113d
Cleared Jan 22, 2002
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
K013465 · LCP
Diabetes Technologies, Inc.
Hematology · 96d
Cleared Jan 22, 2002
PUMP TUBING
K013578 · DWE
Terumo Cardiovascular Systems Corp.
Cardiovascular · 85d
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