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
88897–88920 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 1998
VIVALLOY HR
K982458 · EJJ
Ab Ardent
Dental · 40d
Cleared Aug 24, 1998
VIVACAP HR
K982460 · EJJ
Ab Ardent
Dental · 40d
Cleared Aug 24, 1998
GLASIONOMER CEMENT CX PLUS
K982461 · EMA
Shofu Dental Corp.
Dental · 40d
Cleared Aug 24, 1998
TOKUYAMA SOFRELINER
K982537 · EBI
Tokuyama America, Inc.
Dental · 34d
Cleared Aug 24, 1998
MPS FIXED FLOW RATE SET
K982587 · FPA
Medical Product Specialists
General Hospital · 31d
Cleared Aug 24, 1998
AIRDENT RADIANCE CURING LIGHT
K982615 · EBZ
Air Techniques, Inc.
Dental · 28d
Cleared Aug 24, 1998
SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
K982730 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 39d
Cleared Aug 21, 1998
ELECTROCARDIOGRAPHS
K972587 · LOS
Dr. Lee Co., Ltd.
Cardiovascular · 406d
Cleared Aug 21, 1998
SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS,
K974269 · IYN
Medison America, Inc.
Radiology · 281d
Cleared Aug 21, 1998
GYNEX EXTENDED REACH NEEDLE
K980238 · HEE
Gynex Corp.
Obstetrics & Gynecology · 210d
Cleared Aug 21, 1998
SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY
K980885 · GGP
Shield Diagnostics, Ltd.
Hematology · 165d
Cleared Aug 21, 1998
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
K980976 · HDB
Hollister, Inc.
Obstetrics & Gynecology · 158d
Cleared Aug 21, 1998
ULTRA IMAGE AND ULTRA SCAN
K981028 · ITX
Sonotech, Inc.
Radiology · 155d
Cleared Aug 21, 1998
ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
K981120 · LSE
Zeus Scientific, Inc.
Microbiology · 147d
Cleared Aug 21, 1998
BIPOLAR FEMORAL HEAD
K981238 · KWY
Whiteside Biomechanics, Inc.
Orthopedic · 140d
Cleared Aug 21, 1998
ARGOMEDICAL BIPOLAR SYSTEM
K981451 · KWL
Stelkast Company
Orthopedic · 121d
Cleared Aug 21, 1998
IS-TOXOPLASMA IGG TEST SYSTEM
K981498 · LGD
Diamedix Corp.
Microbiology · 116d
Cleared Aug 21, 1998
MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800
K981568 · GKZ
Cdc Technologies, Inc.
Hematology · 112d
Cleared Aug 21, 1998
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
K981993 · ODA
The Olympus Optical Co.
Radiology · 74d
Cleared Aug 21, 1998
PEDIATRIC INSTATRAK SYSTEM
K981998 · LLZ
Visualization Technology, Inc.
Radiology · 74d
Cleared Aug 21, 1998
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG...
K982238 · MJH
Binax, Inc.
Microbiology · 57d
Cleared Aug 21, 1998
KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS
K982336 · IOR
Invacare Corp.
Physical Medicine · 46d
Cleared Aug 21, 1998
VES 1501-M
K982409 · FWF
Angiolaz, Inc.
General & Plastic Surgery · 42d
Cleared Aug 21, 1998
MEDWORKS INSEMINATION CATHETER
K982628 · MFD
Medworks Corp.
Obstetrics & Gynecology · 24d