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
70585–70608 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2003
ENK FIBEROPTIC ATOMIZER SET
K031966 · EOQ
Cook, Inc.
Ear, Nose, Throat · 112d
Cleared Oct 16, 2003
LTV-1000 VENTILATOR
K032226 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 87d
Cleared Oct 16, 2003
MODEL IR 1200 INSULIN PUMP
K032257 · LZG
Animas Corp.
General Hospital · 86d
Cleared Oct 16, 2003
VISTAKON (GALYFILCON A) SOFT CONTACT LENS
K032340 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 79d
Cleared Oct 16, 2003
MAGNETOM AVANTO MR SYSTEM
K032428 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Oct 16, 2003
PROWESS
K032456 · MUJ
Prowess, Inc.
Radiology · 66d
Cleared Oct 16, 2003
AUTOSET SPIRIT SYSTEM
K032480 · BZD
Resmed, Ltd.
Anesthesiology · 65d
Cleared Oct 16, 2003
INTELEPACS
K032533 · LLZ
Intelerad Medical Systems, Inc.
Radiology · 62d
Cleared Oct 16, 2003
HOLOGIC DR IMAGEPRO
K032546 · LLZ
Hologic, Inc.
Radiology · 59d
Cleared Oct 16, 2003
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
K033009 · CIX
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Oct 16, 2003
ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109
K033099 · FPA
Applied Diabetes Research, Incorporated
General Hospital · 17d
Cleared Oct 16, 2003
SONOLINE ANTARES WITH CLARIFY VE
K033196 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 16, 2003
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND...
K033225 · EOQ
Olympus Optical Co., Ltd.
Ear, Nose, Throat · 10d
Cleared Oct 16, 2003
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
K033244 · OWB
Ge Medical Systems, Inc.
Radiology · 9d
Cleared Oct 15, 2003
ACURA ELITE GRAVITY COMPENSATING RESERVOIR
K030468 · JXG
Phoenix Biomedical Corp.
Neurology · 245d
Cleared Oct 15, 2003
BREAS PV 10I CPAP SYSTEM, MODEL PV 10I
K030985 · BZD
Vital Signs, Inc.
Anesthesiology · 201d
Cleared Oct 15, 2003
DIGITAL AMBULATORY ECG (HOLTER) RECORDER
K031074 · MWJ
Datrix
Cardiovascular · 194d
Cleared Oct 15, 2003
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
K031301 · KGO
Cardinalhealth
General Hospital · 174d
Cleared Oct 15, 2003
DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)
K031408 · FYA
Deroyal
General Hospital · 163d
Cleared Oct 15, 2003
SC TOTAL HIP SYSTEM
K031474 · JDI
Orthopedic Alliance, LLC
Orthopedic · 159d
Cleared Oct 15, 2003
EBI ACUMEN SURGICAL NAVIGATION SYSTEM
K031732 · HAW
Ebi, L.P.
Neurology · 133d
Cleared Oct 15, 2003
BIO-INTRAFIX TIBIAL SCREW AND SHEATH
K032167 · HWC
Mitek Worldwide
Orthopedic · 91d
Cleared Oct 15, 2003
RHYTHM TOUCH Q 2-WAY
K032178 · IPF
Shockim Enterprises, Ltd.
Physical Medicine · 91d
Cleared Oct 15, 2003
COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC...
K032223 · GEI
Cook Vascular, Inc.
General & Plastic Surgery · 86d