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
93817–93840 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1997
CK REAGENT
K971396 · CGS
Carolina Liquid Chemistries Corp.
Chemistry · 44d
Cleared May 29, 1997
SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVE
K971403 · LYY
Sj Medical Products (M) Sdn Bhd
General Hospital · 44d
Cleared May 29, 1997
TYMPANOSTOMY VENTILATION TUBE
K971454 · ETD
Ikonos Corp.
Ear, Nose, Throat · 38d
Cleared May 29, 1997
PATHFINDER SUNGLASSES
K971495 · HQY
Coil
Ophthalmic · 35d
Cleared May 29, 1997
TAS PT-NCTEST CONTROLS
K971748 · GGN
Cardiovascular Diagnostics, Inc.
Hematology · 17d
Cleared May 28, 1997
WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM
K952545 · CBF
Wright Industries
Anesthesiology · 726d
Cleared May 28, 1997
NOTEBOOK IMAGER
K961104 · IYX
Digirad Corp.
Radiology · 434d
Cleared May 28, 1997
CLINITRON RITE-HITE
K964223 · INX
Hill-Rom, Inc.
Physical Medicine · 217d
Cleared May 28, 1997
THERATON 1000E
K964607 · IWD
Theratronics, Inc.
Radiology · 191d
Cleared May 28, 1997
ULTRAVERSE PTA CATHETER
K964881 · LIT
Vas-Cath, Inc.
Cardiovascular · 174d
Cleared May 28, 1997
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP
K970526 · FAS
Arthrocare Corp.
Gastroenterology & Urology · 106d
Cleared May 28, 1997
EARCHECK PRO
K970685 · ETY
Mdi Instruments, Inc.
Ear, Nose, Throat · 93d
Cleared May 28, 1997
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES
K970797 · GEI
Olympus America, Inc.
General & Plastic Surgery · 85d
Cleared May 28, 1997
UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMER
K970828 · ESD
United Hearing Systems, Inc.
Ear, Nose, Throat · 83d
Cleared May 28, 1997
Cordis Endeavor Infusion Catheter
K970842 · QEY
Cordis Corp.
Cardiovascular · 82d
Cleared May 28, 1997
USCI MAINSTAY GUIDING CATHETER
K971034 · DQO
C.R. Bard, Inc.
Cardiovascular · 68d
Cleared May 28, 1997
KASHA VISUAL FIELD SYSTEM
K971156 · HPT
Kasha Software, Inc.
Ophthalmic · 61d
Cleared May 28, 1997
DURALASTIC I AND DURALASTIC II
K971480 · MIB
Allied Biomedical Corp.
General & Plastic Surgery · 35d
Cleared May 28, 1997
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
K971544 · HWE
Synthes (Usa)
Orthopedic · 30d
Cleared May 27, 1997
KSEA CO2 ENDOFLATOR
K963423 · HIF
Karl Storz Endoscopy
Obstetrics & Gynecology · 270d
Cleared May 27, 1997
ORTHOCHUCK
K964252 · GEY
Buckman Co., Inc.
General & Plastic Surgery · 215d
Cleared May 27, 1997
CYBERJET LOCAL ANESTHESIA SYSTEM
K964802 · EGM
Intra Vantage, Inc.
Dental · 179d
Cleared May 27, 1997
CONVERTORS SMS DRAPES
K970554 · KKX
Allegiance Healthcare Corp.
General Hospital · 103d
Cleared May 27, 1997
QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
K970718 · JNM
R&D Systems, Inc.
Immunology · 90d