Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
81649–81672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
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