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
86809–86832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 26, 1999
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
K984288 · DLZ
Ortho-Clinical Diagnostics, Inc.
Toxicology · 56d
Cleared Jan 26, 1999
ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01
K990149 · JJY
Bio-Rad
Chemistry · 7d
Cleared Jan 26, 1999
ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01
K990150 · JJY
Bio-Rad
Chemistry · 7d
Cleared Jan 25, 1999
VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS
K981954 · NRQ
Healthline Implants, Inc.
Dental · 235d
Cleared Jan 25, 1999
FIRSTSAVE BIPHASIC MODELS 9200 AND 9210
K982264 · MKJ
Survivalink Corp.
Cardiovascular · 210d
Cleared Jan 25, 1999
PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM,...
K982432 · KLW
Tinnitus Treatment Centers, Inc.
Ear, Nose, Throat · 196d
Cleared Jan 25, 1999
BLADDERMANAGER PCI 5000 MODEL 1002
K982568 · ITX
Diagnostic Ultrasound Corp.
Radiology · 186d
Cleared Jan 25, 1999
ELECTROSURGICAL DISPERSIVE ELECTRODE
K983782 · GEI
Conmedcorp
General & Plastic Surgery · 90d
Cleared Jan 25, 1999
INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
K983832 · ETY
Idem (Int'L Dist. of Electronics For...
Ear, Nose, Throat · 87d