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
81049–81072 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2000
ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT
K002374 · DZE
Straumann USA
Dental · 89d
Cleared Nov 01, 2000
NUMED TYSHAK II AND Z-MED II PTV CATHETERS
K003052 · LIT
NuMED, Inc.
Cardiovascular · 30d
Cleared Nov 01, 2000
NUMED TYSHAK AND Z-MED PTV CATHETERS
K003114 · LIT
NuMED, Inc.
Cardiovascular · 27d
Cleared Nov 01, 2000
FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H
K003282 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 13d
Cleared Nov 01, 2000
AB-180 XC SYSTEM, MODEL AB-180XC
K991783 · KFM
Cardiacassist, Inc.
Cardiovascular · 526d
Cleared Oct 31, 2000
RIGID GAS PERMEABLE CONTACT LENS
K002025 · HQD
Polymer Technology
Ophthalmic · 120d
Cleared Oct 31, 2000
SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM
K002361 · HRS
Synthes (Usa)
Orthopedic · 89d
Cleared Oct 31, 2000
CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE
K002546 · KNW
CIVCO Medical Instruments Co., Inc.
Gastroenterology & Urology · 75d
Cleared Oct 31, 2000
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
K002556 · MSS
Pharmacia & Upjohn Co.
Ophthalmic · 75d
Cleared Oct 31, 2000
CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER
K002590 · LLZ
Cedara Software Corp.
Radiology · 71d
Cleared Oct 31, 2000
SIGNA MFO/I MAGNETIC RESONANCE SYSTEM
K002611 · LNH
GE Medical Systems
Radiology · 70d
Cleared Oct 31, 2000
ECAT PET SCANNER
K002715 · KPS
Cti Pet Systems, Inc.
Radiology · 61d
Cleared Oct 31, 2000
ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY
K002808 · EJJ
Nordiska Dental AB
Dental · 53d
Cleared Oct 31, 2000
ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY
K002810 · EJJ
Nordiska Dental AB
Dental · 53d
Cleared Oct 31, 2000
ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY
K002811 · EJJ
Nordiska Dental AB
Dental · 53d
Cleared Oct 31, 2000
PLASMAKINETIC GENERATOR
K003060 · GEI
Everest Medical Corp.
General & Plastic Surgery · 29d
Cleared Oct 31, 2000
SEEDNET, MODEL EP6T5, EP5E5
K003065 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 29d
Cleared Oct 31, 2000
SMITH & NEPHEW PISTONS
K003214 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 18d
Cleared Oct 30, 2000
PBN FALLOPIAN TUBE CATHETER SYSTEM
K000620 · MDG
Medical Device Technologies, Inc.
Obstetrics & Gynecology · 249d
Cleared Oct 30, 2000
RESPONDER 3000
K000638 · MKJ
Ge Medical Systems Information...
Cardiovascular · 248d
Cleared Oct 30, 2000
CRANIOCAP
K000861 · MVA
Gillette Children'S Specialty Healthcare
Neurology · 227d
Cleared Oct 30, 2000
KSEA VASCULAR FIBERSCOPES
K001408 · LYK
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 179d
Cleared Oct 30, 2000
NIR BILIARY STENT
K002130 · FGE
Medinol, Ltd.
Gastroenterology & Urology · 108d
Cleared Oct 30, 2000
SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB...
K002188 · DZE
Core-Vent Corp.
Dental · 102d