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
93289–93312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1997
HR12000 ULTRASOUND SYSTEM
K961229 · IYO
International Ultrasound Corp.
Radiology · 426d
Cleared May 29, 1997
SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM
K962142 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 360d
Cleared May 29, 1997
CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS
K963065 · IYO
Shantou Institute of Ultrasonic...
Radiology · 295d
Cleared May 29, 1997
CTS-200 WITH EZU-PL21 TRANSDUCER
K963068 · IYO
Shantou Institute of Ultrasonic...
Radiology · 295d
Cleared May 29, 1997
GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
K963990 · LNH
Philips Medical Systems, Inc.
Radiology · 237d
Cleared May 29, 1997
511 KEV COLLIMATOR
K964438 · KPS
Trionix Research Laboratory, Inc.
Radiology · 205d
Cleared May 29, 1997
QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(
K964767 · JZG
R&D Systems, Inc.
Immunology · 183d
Cleared May 29, 1997
B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC...
K964791 · JZG
Bayer Corp.
Immunology · 181d
Cleared May 29, 1997
ACUPUNCTURE NEEDLES
K964861 · MQX
C.A.M. Supply, Inc.
General Hospital · 176d
Cleared May 29, 1997
ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE
K970803 · MEG
Retractable Technologies, Inc.
General Hospital · 86d
Cleared May 29, 1997
CARDIAC SCORING FOR CT SCANNERS
K970980 · JAK
Elscint, Inc.
Radiology · 72d
Cleared May 29, 1997
DMA TRIGLYCERIDES PROCEDURES
K971113 · CDT
Data Medical Associates, Inc.
Chemistry · 63d
Cleared May 29, 1997
FRIGIDERM FRIGISPRAY
K971216 · GEH
Dermatologic Lab & Supply, Inc.
General & Plastic Surgery · 57d
Cleared May 29, 1997
CHOL OR CHOLESTEROL
K971345 · CHH
Carolina Liquid Chemistries Corp.
Chemistry · 49d
Cleared May 29, 1997
VARIOLINK II
K971372 · EBF
Ivoclar North America, Inc.
Dental · 45d
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