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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
92497–92520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 01, 1997
UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)
K971992 · FHA
Uromed Corp.
Gastroenterology & Urology · 64d
Cleared Aug 01, 1997
PHONAK EPICA
K972105 · ESD
Phonak, Inc.
Ear, Nose, Throat · 57d
Cleared Aug 01, 1997
CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE...
K972160 · DCK
Trinity Laboratories, Inc.
Immunology · 53d
Cleared Aug 01, 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K972180 · JWY
Dade Microscan, Inc.
Microbiology · 52d
Cleared Aug 01, 1997
ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING...
K972239 · ELW
Zhermack S.P.A.
Dental · 46d
Cleared Aug 01, 1997
INNOFLUOR GENTAMICIN ASSAY SYSTEM
K972331 · LGQ
Oxis Intl., Inc.
Toxicology · 39d
Cleared Aug 01, 1997
QUICKSTICK ONE STEP HCG PREGNANCY TEST
K972682 · LCX
Phamatech
Chemistry · 15d
Cleared Aug 01, 1997
MODIFICATION OF EST CULTURE SYSTEM II - MYCO
K972756 · MDB
Accumed Intl., Inc.
Microbiology · 63d
Cleared Jul 31, 1997
BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT...
K963512 · HQD
Benz Research and Development Corp.
Ophthalmic · 335d