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
87313–87336 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1999
AURORA
K972065 · DQY
Neurovena Corp.
Cardiovascular · 603d
Cleared Jan 27, 1999
ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972616 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 562d
Cleared Jan 27, 1999
GT LEGGIERO
K981359 · DQY
Terumo Medical Corp.
Cardiovascular · 288d
Cleared Jan 27, 1999
LACTOSORB MENISCAL REPAIR DEVICE
K982095 · MAI
Biomet, Inc.
Orthopedic · 226d
Cleared Jan 27, 1999
INVACARE CPAP
K982242 · BZD
Invacare Corp.
Anesthesiology · 216d
Cleared Jan 27, 1999
MERCATOR
K982384 · DSH
Harley Street Software , Ltd.
Cardiovascular · 203d
Cleared Jan 27, 1999
CHAIT CECOSTOMY CATHETER
K982500 · KNT
Cook, Inc.
Gastroenterology & Urology · 191d
Cleared Jan 27, 1999
VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM
K982506 · GEH
Cryosurgery, Inc.
General & Plastic Surgery · 191d
Cleared Jan 27, 1999
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007,...
K982540 · MTD
Cardiac Pathways Corp.
Cardiovascular · 190d
Cleared Jan 27, 1999
ENDIUS SPINE ENDOSCOPE
K982819 · GWG
Endius, Inc.
Neurology · 169d
Cleared Jan 27, 1999
KAVO KEY LASER 1242
K983100 · GEX
Kavo America
General & Plastic Surgery · 146d
Cleared Jan 27, 1999
SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE
K983988 · HRS
Syntec Scientific Corp.
Orthopedic · 79d
Cleared Jan 26, 1999
CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972615 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 561d
Cleared Jan 26, 1999
PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM
K982090 · DXH
Paceart, Inc.
Cardiovascular · 225d
Cleared Jan 26, 1999
VAGABOND SOFT RESTRAINT SYSTEM
K982178 · FMQ
Emergent Innovations, Ltd.
General Hospital · 218d
Cleared Jan 26, 1999
BICON BONE SCREW SYSTEM
K982488 · DZE
Bicon, Inc.
Dental · 193d
Cleared Jan 26, 1999
TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT...
K983145 · LYY
Shen Wei (Usa), Inc.
General Hospital · 140d
Cleared Jan 26, 1999
APOB
K983281 · DFC
Abbott Laboratories
Immunology · 130d
Cleared Jan 26, 1999
MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU...
K983799 · GWM
Medtronic PS Medical
Neurology · 90d
Cleared Jan 26, 1999
KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR
K983809 · MQN
KLS-Martin L.P.
Dental · 90d
Cleared Jan 26, 1999
VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER
K983912 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 84d
Cleared Jan 26, 1999
NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY
K983992 · JZO
Nichols Institute Diagnostics
Immunology · 78d
Cleared Jan 26, 1999
PLANMECA INTRACAM STATION
K984013 · EIA
Planmeca Oy
Dental · 76d
Cleared Jan 26, 1999
PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)
K984260 · DYB
Terumo Medical Corp.
Cardiovascular · 62d