FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
133201–133224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 24, 1989
DOUBLE ANTIBODY SERUM BENZODIAZEPINES
K890001 · JXM
Diagnostic Products Corp.
Toxicology · 21d
Cleared Jan 24, 1989
BAXTER STERILE TOWEL
K890006 · KKX
Healthmed Corp.
General Hospital · 21d
Cleared Jan 24, 1989
DISPOSABLE COLOR-CUFFS
K890014 · KCY
Instrumed, Inc.
General & Plastic Surgery · 21d
Cleared Jan 24, 1989
STERILE LACERATION TRAY
K890071 · LRP
Mumtaz I. Malik
General & Plastic Surgery · 15d
Cleared Jan 24, 1989
MODERN LATEX STERILE SURGICAL GLOVES
K890073 · KGO
Modern Rubber Co., Ltd. C/O World...
General Hospital · 15d
Cleared Jan 24, 1989
DANEK IRRIGATING BURR (DIB) SET
K890090 · GFF
Danek Medical, Inc.
General & Plastic Surgery · 14d
Cleared Jan 24, 1989
KLEEN TEST O.R. KIT
K890098 · LRO
Kleen Test Products
General & Plastic Surgery · 14d
Cleared Jan 24, 1989
BARD TAB ECG MONITORING ELECTRODE
K890103 · DRX
C.R. Bard, Inc.
Cardiovascular · 14d
Cleared Jan 24, 1989
MODIFIED CUSHION-FLEX(TM)
K890108 · BSJ
Life Design Systems, Inc.
Anesthesiology · 21d
Cleared Jan 24, 1989
BR-S601MU (SURGICAL VIDEO RECORDER)
K890119 · FWC
Victor Co. of Japan, Ltd. C/O Jvc Corp.
General & Plastic Surgery · 13d