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
95473–95496 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1997
PHOENIX ETE TISSUE EXTENSION SYSTEM
K962144 · MKY
Phoenix Biomedical Corp.
General & Plastic Surgery · 225d
Cleared Jan 14, 1997
HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
K962220 · BZE
Marquest Medical Products, Inc.
Anesthesiology · 218d
Cleared Jan 14, 1997
WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
K962223 · BTT
Marquest Medical Products, Inc.
Anesthesiology · 218d
Cleared Jan 14, 1997
OLYMPUS LIPASE REAGENT
K963424 · CDT
Olympus America, Inc.
Chemistry · 137d
Cleared Jan 14, 1997
SEGUE INFUSION CATHETER
K964154 · KRA
Interventional Innovations Corp.
Cardiovascular · 90d
Cleared Jan 14, 1997
METAL ACETABULAR COMPONENT
K964227 · LPH
Encore Orthopedics, Inc.
Orthopedic · 83d
Cleared Jan 14, 1997
BRIDGE LONG STEM FEMORAL COMPONENT
K964249 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 82d
Cleared Jan 14, 1997
ALPHA POSTERIOR SPINAL SYSTEM
K964275 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 81d
Cleared Jan 13, 1997
GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET
K960511 · DWJ
Gibeck, Inc.
Cardiovascular · 343d
Cleared Jan 13, 1997
VERSA-CATH ARTERIAL CATHETER
K961883 · DXE
Ideas For Medicine, Inc.
Cardiovascular · 243d
Cleared Jan 13, 1997
STAT IM 5000 CASSETTE AUTOCLAVE
K962179 · FLE
Scican
General Hospital · 221d
Cleared Jan 13, 1997
MISTY OX TURBOHEATER
K962438 · CAF
Vital Signs, Inc.
Anesthesiology · 203d
Cleared Jan 13, 1997
FOUR-CHANNEL PREAMPLIFIER
K962455 · GWF
Cadwell Laboratories, Inc.
Neurology · 202d
Cleared Jan 13, 1997
TWO-CHANNEL PREAMPLIFIER
K962457 · GWF
Cadwell Laboratories, Inc.
Neurology · 202d
Cleared Jan 13, 1997
CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER
K962458 · GWF
Cadwell Laboratories, Inc.
Neurology · 202d
Cleared Jan 13, 1997
CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
K962873 · OVQ
Vysis
Pathology · 174d
Cleared Jan 13, 1997
REP 3 QUTO-FLUR CHOLESTEROL-30
K962914 · JHO
Helena Laboratories
Chemistry · 171d
Cleared Jan 13, 1997
MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER
K963092 · DQO
Adam Spencer Corp.
Cardiovascular · 158d
Cleared Jan 13, 1997
11F GUIDING CATHETER
K963663 · DQY
Boston Scientific /International...
Cardiovascular · 122d
Cleared Jan 13, 1997
ASC HIGH PRESSURE BRAIDED TUBES
K964331 · DQO
Adam Spencer Corp.
Cardiovascular · 75d
Cleared Jan 13, 1997
AIA-PACK B12 ASSAY
K964348 · CDD
Tosoh Medics, Inc.
Chemistry · 74d
Cleared Jan 13, 1997
SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)
K964403 · HGX
The First Years, Inc.
Obstetrics & Gynecology · 70d
Cleared Jan 13, 1997
ROCHE COBAS IBTEGRA REAGENT CASSETTES
K964457 · JQB
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared Jan 13, 1997
VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
K964587 · LEH
Bayer Corp.
Toxicology · 59d