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
80521–80544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 2000
QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3
K001249 · JJY
Consolidated Technologies of Wisconsin
Chemistry · 204d
Cleared Nov 02, 2000
ACCUWELL TSH, MODEL KAW-TSH-960
K001455 · JLW
Neometrics, Inc.
Chemistry · 177d
Cleared Nov 02, 2000
OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL...
K001676 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 154d
Cleared Nov 02, 2000
SIMPLICITY SPINAL SYSTEM
K002103 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 113d
Cleared Nov 02, 2000
QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H
K002390 · JFB
Lsi Intl., Inc.
Physical Medicine · 90d
Cleared Nov 02, 2000
VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
K002392 · GWM
Integra Neurocare, LLC
Neurology · 87d
Cleared Nov 02, 2000
MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
K002456 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 84d
Cleared Nov 02, 2000
HARDYDISK CLINDAMYCIN, 2MCG
K002662 · JTN
Hardy Diagnostics
Microbiology · 69d
Cleared Nov 02, 2000
R&D PROJECT DW271#11A
K002872 · EJT
Ivoclar North America, Inc.
Dental · 49d
Cleared Nov 02, 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
K003112 · JJX
Ortho-Clinical Diagnostics, Inc.
Microbiology · 29d
Cleared Nov 02, 2000
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
K003131 · JDW
Biomet, Inc.
Orthopedic · 27d
Cleared Nov 02, 2000
RETINADX
K003236 · HKI
Regulatory Associates, Inc.
Ophthalmic · 16d
Cleared Nov 01, 2000
CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM
K001948 · DXN
Hypertension Diagnostics, Inc.
Cardiovascular · 128d
Cleared Nov 01, 2000
SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)
K002362 · MQV
Synthes (Usa)
Orthopedic · 90d
Cleared Nov 01, 2000
MEDOVATIONS ESOPHAGEAL DILATOR
K002363 · KNQ
Medovations, Inc.
Gastroenterology & Urology · 90d
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