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
80953–80976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 12, 2000
USS VAS
K002517 · KWP
Synthes (Usa)
Orthopedic · 28d
Cleared Sep 12, 2000
EL-ANA PROFILES-2K1
K002559 · LJM
Theratest Laboratories, Inc.
Immunology · 26d
Cleared Sep 12, 2000
MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND...
K002607 · KWP
Depuyacromed
Orthopedic · 21d
Cleared Sep 12, 2000
MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022
K991502 · JXG
Medtronic PS Medical
Neurology · 502d
Cleared Sep 11, 2000
TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
K001461 · KPE
Biometrix , Ltd.
General Hospital · 124d
Cleared Sep 11, 2000
VIRIDIS LASER
K001784 · GEX
Cosmos Medical Technology
General & Plastic Surgery · 90d
Cleared Sep 11, 2000
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
K001900 · LRM
Helix Diagnostics, Inc.
Immunology · 81d
Cleared Sep 11, 2000
C02 LASER MULTIPULSE
K002032 · GEX
Asclepion-Meditec AG
General & Plastic Surgery · 70d
Cleared Sep 11, 2000
FMS SOLO
K002040 · HRX
Future Medical Systems, Inc.
Orthopedic · 68d