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
81457–81480 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2000
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE
K000138 · LZA
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED
K000139 · LZA
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED
K000141 · LYY
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE
K000142 · LYY
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED
K000143 · LZA
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE
K000145 · LZA
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR...
K002087 · LYY
Qingdao Bestex Rubber & Plastic...
General Hospital · 65d
Cleared Sep 13, 2000
ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
K002290 · CHL
Radiometer Medical A/S
Chemistry · 48d
Cleared Sep 13, 2000
MOTOR-DRIVE MANIPULATOR MM-89
K002291 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 48d
Cleared Sep 13, 2000
3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE
K002293 · MQJ
Narishige Co., Ltd.
Obstetrics & Gynecology · 48d
Cleared Sep 13, 2000
COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
K002383 · MQL
Cook Ob/Gyn
Obstetrics & Gynecology · 40d
Cleared Sep 13, 2000
MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM
K002544 · DQK
Oxford Instruments
Cardiovascular · 27d
Cleared Sep 13, 2000
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K002591 · DTP
Cobe Cardiovascular, Inc.
Cardiovascular · 23d
Cleared Sep 13, 2000
METHAFILCON A
K002625 · LPL
CooperVision, Inc.
Ophthalmic · 21d
Cleared Sep 13, 2000
MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS
K002647 · LPL
Marietta Contact Lens Service
Ophthalmic · 20d
Cleared Sep 13, 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...
K002682 · DQA
Masimo Corp.
Anesthesiology · 16d
Cleared Sep 13, 2000
POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING...
K002701 · LYY
Alliance Rubber Products Sdn. Bhd.
General Hospital · 14d
Cleared Sep 13, 2000
PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
K992476 · MWS
Pilling Weck Surgical
Cardiovascular · 415d
Cleared Sep 13, 2000
HUMID-HEAT
K993773 · BTT
Hudson Rcj AB
Anesthesiology · 310d
Cleared Sep 13, 2000
ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER...
K994137 · LYC
Atrix Laboratories, Inc.
Dental · 281d
Cleared Sep 12, 2000
INSIGHT IMAGE GUIDED SURGICAL SYSTEM
K001642 · HAW
Surgical Insights, Inc.
Neurology · 105d
Cleared Sep 12, 2000
ACCUWARM EMG HEAT LAMP
K001800 · IKN
Rjl Associates, LLC
Neurology · 90d
Cleared Sep 12, 2000
REFRACTIVE SURGERY BLADES
K001806 · HNO
Millennium Biomedical, Inc.
Ophthalmic · 89d
Cleared Sep 12, 2000
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
K002044 · HLJ
Magna Fortis Corporation
Ophthalmic · 69d