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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
132601–132624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1989
ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS
K881344 · DIC
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 300d
Cleared Jan 24, 1989
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
K882517 · HLI
Rodenstock Instrument Corp.
Ophthalmic · 221d
Cleared Jan 24, 1989
SOFTRAC-PTA PERIPHERAL DILATATION CATHETER
K882826 · LIT
Schneider-Shilley (Usa)
Cardiovascular · 200d
Cleared Jan 24, 1989
MODELS 4000/4900/6000/8000/8900 ND:YAG & 1700 CO2
K883379 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 167d
Cleared Jan 24, 1989
TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA
K883720 · LGD
Lmd Laboratories
Microbiology · 146d
Cleared Jan 24, 1989
MAGNETOM 42 SP AND MAGNETOM 63 SP
K883898 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 131d
Cleared Jan 24, 1989
ROTACUBE
K884017 · LIQ
Difco Laboratories, Inc.
Microbiology · 124d
Cleared Jan 24, 1989
LUNDY VAPORIZER SYSTEM
K884090 · CAD
Vaporflow Technology, Inc.
Anesthesiology · 118d
Cleared Jan 24, 1989
DU PONT ANALYST THYROID ROTOR
K884169 · CEL
The DU Pont Co.
Chemistry · 112d
Cleared Jan 24, 1989
SURGILASE YAG 100 SURGIPROBES & SURGISCALPEL
K884182 · GEX
Surgilase, Inc.
General & Plastic Surgery · 118d
Cleared Jan 24, 1989
AMX-110, AMX-II AND AMX-III
K884340 · ILZ
Dyna-Med
Radiology · 102d
Cleared Jan 24, 1989
PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER
K884534 · JPA
Pall Biomedical Products Co.
Hematology · 88d
Cleared Jan 24, 1989
KOENIG TOTAL TOE IMPLANT
K884561 · LZJ
Dow Corning Wright
Orthopedic · 85d
Cleared Jan 24, 1989
EBV-VCA ANTIBODY (IGG)
K884591 · GNP
Hillcrest Biologicals
Microbiology · 82d
Cleared Jan 24, 1989
NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS
K884618 · GKL
Nova Biomedical Corp.
Hematology · 81d
Cleared Jan 24, 1989
CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700
K884640 · KRI
American Omni Medical, Inc.
Cardiovascular · 78d
Cleared Jan 24, 1989
SARNS 9000 WITH CENTRIFUGAL PUMP OPTION
K884659 · KFM
3M Health Care, Sarns
Cardiovascular · 78d
Cleared Jan 24, 1989
ACCULITE-PPL 5
K884787 · INE
Medical Alignment Systems
Radiology · 70d
Cleared Jan 24, 1989
PLEUR-EVAC(R) A-7002--ADULT/PEDIATRIC DRAINAGE
K884844 · CAC
Deknatel, Inc.
Anesthesiology · 64d
Cleared Jan 24, 1989
STANDARD ADMINISTRATION SETS
K885030 · FPA
3M Company
General Hospital · 50d
Cleared Jan 24, 1989
ACCESS R-CLONE ANA PROFILE ASSAY
K885048 · DHC
Lipogen, Inc.
Immunology · 48d
Cleared Jan 24, 1989
KRUPIN EYE VALVE W/SCLERAL BUCKLE
K885125 · KYF
Hood Laboratories
Ophthalmic · 43d
Cleared Jan 24, 1989
GAUZE SWABS, NON-STERILE
K885142 · EFQ
Smith & Nephew, Inc.
General & Plastic Surgery · 40d
Cleared Jan 24, 1989
ASSENAT-BLESCHET SUNGLASSES
K885275 · HQY
Roseburg SA
Ophthalmic · 28d