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
93001–93024 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1997
PLASMA CATECHOLAMINE KIT
K972167 · CHQ
Bioanalytical Systems, Inc.
Chemistry · 56d
Cleared Aug 04, 1997
RHINOCELL NASAL PACKINGS
K972459 · EMX
Boston Medical Products, Inc.
Ear, Nose, Throat · 34d
Cleared Aug 04, 1997
BELL PROSTHESIS (PARTIAL)
K972492 · ETB
Heinz Kurz
Ear, Nose, Throat · 33d
Cleared Aug 04, 1997
METHADONE EIA ASSAY
K972526 · DJR
Diagnostic Reagents, Inc.
Toxicology · 39d
Cleared Aug 04, 1997
AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL...
K972585 · ETA
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 25d
Cleared Aug 04, 1997
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
K972608 · JJY
Randox Laboratories, Ltd.
Immunology · 54d
Cleared Aug 01, 1997
RELIEFBAND TENS UNIT (MODIFICATION)
K961050 · GZJ
Maven Labs, Inc.
Neurology · 540d
Cleared Aug 01, 1997
N-ASSAY TIA APO A1 TEST KIT
K964292 · DER
Crestat Diagnostics, Inc.
Immunology · 276d
Cleared Aug 01, 1997
N-ASSAY TIA APO A1/B MULTI CALIBRATOR
K964294 · DER
Crestat Diagnostics, Inc.
Immunology · 276d
Cleared Aug 01, 1997
N-ASSAY TIA APO B TEST KIT
K964296 · DER
Crestat Diagnostics, Inc.
Immunology · 276d
Cleared Aug 01, 1997
SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
K965187 · GZJ
Sparta Surgical Corp.
Neurology · 220d
Cleared Aug 01, 1997
SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS)
K970048 · KWQ
Synthes (Usa)
Orthopedic · 207d
Cleared Aug 01, 1997
MEDI-DYNE GUIDING CATHETER
K970401 · DQY
Medi-Dyne, Inc.
Cardiovascular · 179d
Cleared Aug 01, 1997
GRAFT PATCH
K970561 · FTL
Organogenesis, Inc.
General & Plastic Surgery · 169d
Cleared Aug 01, 1997
GLUCOSE REAGENT
K970664 · CFR
Derma Media Lab., Inc.
Chemistry · 161d
Cleared Aug 01, 1997
AEROQUIP SAFESTART IV CATHETER
K970669 · FOZ
Aeroquip Medical Products
General Hospital · 158d
Cleared Aug 01, 1997
DOUBLE LUMEN PICC
K970926 · LJS
B.Braun Medical, Inc.
General Hospital · 141d
Cleared Aug 01, 1997
GOLDEN EAGLE
K971043 · INI
Golden Technologies, Inc.
Physical Medicine · 133d
Cleared Aug 01, 1997
GOLDEN HAWK
K971050 · INI
Golden Technologies, Inc.
Physical Medicine · 133d
Cleared Aug 01, 1997
UREA
K971309 · CDQ
Derma Media Lab., Inc.
Chemistry · 115d
Cleared Aug 01, 1997
REGANES SPINAL NEEDLE (VARIOUS)
K971645 · MIA
Avid N.I.T., Inc.
Anesthesiology · 88d
Cleared Aug 01, 1997
IMPROVEMENTS TO THE MEHL RUBY LASER
K971814 · GEX
Mehl/Biophile Intl., Inc.
General & Plastic Surgery · 78d
Cleared Aug 01, 1997
PORT-NEB
K971933 · CAF
Medic-Aid , Ltd.
Anesthesiology · 66d
Cleared Aug 01, 1997
INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER
K971950 · HQF
Infinitech, Inc.
Ophthalmic · 65d